Alphatec Spine, Inc.
Alphatec Spine, Inc. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2026, with 46 FDA device recalls on record.
Top product codes for Alphatec Spine, Inc.
FDA recalls by Alphatec Spine, Inc.
10 most recent of 46- Z-2793-2026 — SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
- Z-1343-2026 — ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.
- Z-1342-2026 — ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.
- Z-1065-2025 — Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nonsterile; (3) Calibrate CCX-O, 7 x 10 x 25mm 15 degrees, Part #325-07102515, nonsterile; (4) Calibrate CCX-O, 7 X 10 X 30mm 5 degrees, Part #325-07103005, nonsterile; (5) Calibrate CCX-O, 7 x 10 x 30mm 10 degrees, Part #325-07103010, nonsterile; (6) Calibrate CCX-O, 7 x 10 x 30mm 15 degrees, Part #325-07103015, nonsterile; (7) Calibrate CCX-O, 7 x 10 x 35mm 10 degrees, Part #325-07103510, nonsterile; (8) Calibrate CCX-O, 7 x 10 x 35mm 15 degrees, Part #325-07103515, nonsterile; (9) Calibrate CCX-O, 9 x 10 x 25mm 5 degrees, Part #325-09102505, nonsterile; (10) Calibrate CCX-O, 9 x 10 x 25mm 10 degrees, Part #325-09102510, nonsterile; (11) Calibrate CCX-O, 9 x 10 x 30mm 5 degrees, Part #325-09103005, nonsterile; (12) Calibrate CCX-O, 9 x 10 x 30mm 10 degrees, Part #325-09103010, nonsterile; (13) Calibrate CCX-O, 11 x 10 x 30mm 10 degrees, Part #325-11103010, nonsterile; (14) Calibrate CCX-S, 7 x 10 x 22mm 5 degrees, Part #326-07102205, nonsterile; (15) Calibrate CCX-S, 7 x 10 x 22mm 10 degrees, Part #326-07102210, nonsterile; (16) Calibrate CCX-S, 7 x 10 x 22mm 15 degrees, Part #326-07102215, nonsterile; (17) Calibrate CCX-S, 7 x 10 x 26mm 5 degrees, Part #326-07102605, nonsterile; (18) Calibrate CCX-S, 7 x 10 x 26mm 10 degrees, Part #326-07102610, nonsterile; (19) Calibrate CCX-S, 7 x 10 x 26mm 15 degrees, Part #326-07102615, nonsterile; (20) Calibrate CCX-S, 7 x 10 x 30mm 10 degrees, Part #326-07103010, nonsterile; (21) Calibrate CCX-S, 9 x 10 x 22mm 5 degrees, Part #326-09102205, nonsterile; (22) Calibrate CCX-S, 9 x 10 x 22mm 10 degrees, Part #326-09102210, nonsterile; (23) Calibrate CCX-S, 9 x 10 x 26mm 5 degrees, Part #326-09102605, nonsterile; (24) Calibrate CCX-S, 9 x 10 x 26mm 10 degrees, Part #326-09102610, nonsterile; and (25) Calibrate CCX-S, 11 x 10 x 26mm 10 degrees, Part #326-11102610, nonsterile. Convenience kits containing affected implants: (1) Calibrate CCX Oblique Implants, REF CLCCXOIMPA, containing 24 implants/kit, nonsterile; and (2) Calibrate CCX Straight Implants, REF CLCCXSIMPA, containing 36 implants/kit, nonsterile.
- Z-1182-2024 — IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm 132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm 132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm 132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm 232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm 232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm 232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm 232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm The IdentiTi ALIF Standalone Interbody System is an integrated intervertebral body fusion device for use in anterior lumbar interbody fusion (ALIF) procedures.
- Z-2475-2023 — LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,
- Z-0196-2023 — Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm, 15¿ TC11050 00840180510810 CI-11050-09102515 Longer IdentiTi PO Trial Tip, 12A X 9P X 10 X 25mm, 15¿ TC11050 00840180510827 CI-11050-10102515 Longer IdentiTi PO Trial Tip, 13A X 10P X 10 X 25mm, 15¿ TC11050 00840180510834 CI-11050-11102515 Longer IdentiTi PO Trial Tip, 14A X 11P X 10 X 25mm, 15¿ TC11050 00840180510841 CI-11050-12102515 Longer IdentiTi PO Trial Tip, 15A X 12P X 10 X 25mm, 15¿ TC11050 00840180510858 CI-11051-10-07 Longer Rotating Disc Shaver, Parallel, 7mm TC11051 00840180511084 CI-11051-20-13 Longer Rotating Disc Shaver, Parallel, 13mm TC11051 00840180511145 CI-11051-20-15 Longer Rotating Disc Shaver, Parallel, 15mm TC11051 00840180511169 CI-11051-20-09 Longer Rotating Disc Shaver, Parallel, 9mm TC11051 00840180511107 CI-11051-20-08 Longer Rotating Disc Shaver, Parallel, 8mm TC11051 00840180511091 CI-11051-20-11 Longer Rotating Disc Shaver, Parallel, 11mm TC11051 00840180511121 CI-11051-10-06 Longer Rotating Disc Shaver, Parallel, 6mm TC11051 00840180511077 CI-11051-20-10 Longer Rotating Disc Shaver, Parallel, 10mm TC11051 00840180511114 CI-11051-20-14 Longer Rotating Disc Shaver, Parallel, 14mm TC11051 00840180511152 CI-11051-10-05 Longer Rotating Disc Shaver, Parallel, 5mm TC11051 00840180511060 CI-11051-20-12 Longer Rotating Disc Shaver, Parallel, 12mm TC11051 00840180511138 CI-11052-01-022-05 Longer Straight Curette, Size 2 TC11052 00840180511282 CI-11052-02-022-05 Longer Up-Angled Pull Curette, Size 2 TC11052 00840180511299 CI-11052-04-022-05 Longer Right-Angled Pull Curette, Size 2 TC11052 00840180511305 CI-11052-05-022-05 Longer Left-Angled Curette, Size 2 TC11052 00840180511312 CI-11071-021-05 Longer Straight Teardrop Curette, Size 2 TC11071 00840180511275
- Z-1821-2021 — Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613
- Z-1812-2021 — Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415
- Z-1827-2021 — Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Alphatec Spine, Inc.
- K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
- K253216 — IntraOp Alignment System; CONTOUR3D Bending System
- K253615 — Invictus Bands System
- K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
- K252842 — SafeOp 3: Neural Informatix System
- K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)
- K251080 — IdentiTi II Cervical Interbody System
- K243461 — Calibrate Interbody Systems
- K242364 — IdentiTi II Interbody System
- K242147 — Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System
- K241519 — Invictus® Small Stature Spinal Fixation System
- K240199 — IntraOp Alignment System
- K234092 — SafeOp 3: Neural Informatix Systeem
- K233640 — Segmental Plating System (SPS) +4 more
- K232345 — ATEC Posterior Navigated Disc Prep Instruments
- K232504 — Calibrate CCX Interbody System
- K232044 — Invictus Robotic Navigation Instruments
- K232173 — Ascend VBR System, Ascend NanoTec VBR System
- K232275 — Invictus® Spinal Fixation System
- K232097 — IdentiTi ALIF Interbody Systems
- K232413 — Fusion Robotic Navigation System
- K231438 — Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System
- K230721 — ATEC Lateral Plate System
- K223611 — Calibrate LTX Interbody System
- K223765 — ATEC Lateral Navigation Instruments
- K221926 — Invictus® Bone Cement, Invictus Spinal Fixation System
- K222455 — Calibrate LTX Interbody System
- K222973 — IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem
- K221821 — ATEC IOM Accessory Instruments
- K220782 — IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody System
- K214006 — Invictus® Spinal Fixation System
- K213849 — SafeOp 2: Neural Informatix System
- K213443 — Insignia Anterior Cervical Plate System
- K213460 — Invictus Spinal Fixation System
- K211987 — ATEC Alignment App
- K211805 — IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System
- K211873 — PSX Interbody System
- K203742 — IdentiTi ALIF Standalone Interbody System
- K202812 — IdentiTi Cervical Standalone Interbody System
- K203125 — Invictus OCT Spinal Fixation System
- K203056 — Invictus Spinal Fixation System
- K202587 — ATEC Lateral Interbody System
- K202327 — Invictus OsseoScrew® System
- K200936 — Invictus CT Spinal Fixation System
- K200995 — Insignia Anterior Cervical Plate System
- K192938 — Invictus Spinal Fixation System
- K191723 — ATEC IOM Accessory Instruments
- K191311 — ATEC Lateral Interbody System
- K182617 — ATEC IOM Accessory Instruments
- K183705 — IdentiTi Porous Ti Interbody System
- K182746 — ATEC ALIF and LLIF Spacer System
- K182808 — Aspida® Anterior Lumbar Plating System
- K181980 — OsseoScrew System
- K181435 — ATEC Cervical Spacer System
- K181677 — Kodiak Spinal Fixation System
- K181453 — ATEC ALIF Spacer System
- K180480 — ATEC Universal Spacer System
- K173522 — Solanas® Posterior Stabilization System
- K160646 — XYcor® Expandable Spinal Spacer System
- K161363 — Arsenal Spinal Fixation System
- K153603 — Alphatec Navigation Instruments
- K152968 — Arsenal Spinal Fixation System
- K143740 — Battalion Universal Spacer System
- K143149 — Arsenal Spinal Fixation System
- K133221 — ARSENAL SPINAL FIXATION SYSTEM
- K131119 — SOLANAS POSTERIOR STABILIZATION SYSTEM
- K130548 — EPICAGE INTERBODY FUSION DEVICE
- K123993 — SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
- K123623 — ILLICO MIS POSTERIOR FIXATION SYSTEM
- K123218 — ILLICO FS FACET FIXATION SYSTEM
- K111634 — XENON(TM) PEDICLE SCREW SYSTEM
- K110170 — RAPTOR FACET FIXATION SYSTEM
- K111076 — SOLANAS AVALON POSTERIOR FIXATION SYSTEM
- K103205 — BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM
- K102402 — SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM
- K102820 — APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
- K101255 — ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM
- K100685 — ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
- K100138 — ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
- K093077 — ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
- K091189 — ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
- K090779 — ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
- K090425 — GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM
- K090228 — ROC LUMBAR PLATING SYSTEM
- K090782 — NOVEL ALIF SPINAL SPACER SYSTEM
- K081730 — NOVEL CERVICAL SPINAL SPACER SYSTEM
- K081158 — ZODIC POLYAXIAL SPINAL FIXATION SYSTEM
- K080699 — NOVEL SPINAL SPACER SYSTEM
- K071890 — ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM
- K072081 — ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM
- K071380 — MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
- K063668 — ROC LUMBAR SYSTEM
- K070681 — NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM
- K061321 — ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX
- K052201 — SOLANAS POSTERIOR STABILIZATION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.