Stryker Spine
Stryker Spine holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2026, with 29 FDA device recalls on record.
Top product codes for Stryker Spine
FDA recalls by Stryker Spine
10 most recent of 29- Z-1491-2025 — Monterey AL Implant Inserter; 22mm; Catalog 48019140.
- Z-1490-2025 — Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.
- Z-1489-2025 — Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
- Z-1488-2025 — Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
- Z-3210-2024 — AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.
- Z-0610-2024 — LITe Decompression Snake Arm, REF 48080230
- Z-2101-2021 — Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
- Z-2100-2021 — Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
- Z-1437-2021 — Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102).
- Z-0092-2019 — AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS¿ ARIA TM PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
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 Stryker Spine
- K262061 — Tritanium® C Anterior Cervical Cage +16 more
- K261008 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip +7 more
- K242361 — OZARK Cervical Plate System +13 more
- K242280 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips
- K222684 — XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2 Spinal System, ES2 Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi
- K221490 — Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer
- K203205 — Navigated Spine Instruments
- K200666 — Stryker Xia 3 Power Adaptor
- K183249 — Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage
- K183071 — VLIFT-s Vertebral Body Replacement System
- K181014 — Tritanium PL Cage
- K171496 — Tritanium C Anterior Cervical Cage
- K161407 — Ascential IBD PEEKc Spacer
- K152532 — AERO -C Cervical Cage System
- K133188 — MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL
- K132968 — UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)
- K122845 — ES2 SPINAL SYSTEM MODEL 48280XXXX
- K122637 — LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
- K120869 — ANCHOR-L LUMBAR CAGE
- K113666 — XIA 3 SPINAL SYSTEM
- K120486 — AVS AS PEEK SPACER
- K113802 — ESCALATE LAMINOPLASTY SYSTEM
- K111719 — OASYS SPINAL SYSTEM
- K110419 — AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
- K102606 — AVS ANCHOR-C CERVICAL CAGE SYSTEM
- K101183 — MODIFICATION TO: OASYS SYSTEM
- K102235 — MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM
- K101051 — AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX
- K100865 — AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX
- K101144 — MODIFICATION TO:RADIUS SPINAL SYSTEM
- K100737 — MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM
- K093670 — MODIFICATION TO: OASYS SYSTEM
- K092605 — XIA 4.5 SPINAL SYSTEM
- K091946 — VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX
- K092631 — MANTIS REDUX SPINAL SYSTEM
- K091291 — XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD
- K083393 — XIA 3 SPINAL SYSTEM
- K082608 — RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601
- K080773 — THOR ANTERIOR PLATING SYSTEM
- K080928 — XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS
- K073470 — AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX
- K080143 — MODIFICATION TO STRYKER SPINE OASYS SYSTEM
- K073437 — THOR ANTERIOR PLATING SYSTEM
- K072568 — MODIFICATION TO OASYS SYSTEM
- K071373 — STRYKER SPINE XIA III SPINAL SYSTEM
- K070631 — DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM
- K063430 — ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
- K063428 — XIA STAINLESS STEEL SPINAL SYSTEM
- K062270 — RADIUS SPINAL SYSTEM
- K062853 — MODIFICATION TO STRYKER SPINE OASYS SYSTEM
- K062698 — TRIO + SPINAL SYSTEM
- K061813 — MANTIS SPINAL SYSTEM
- K062310 — REFLEX HYBRID ACP SYSTEM
- K062132 — AVS PL PEEK SPACER SYSTEM
- K061836 — AVS ASL PEEK SPACER SYSTEM
- K061854 — XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM
- K060506 — STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM
- K060979 — XIA TITANIUM AND 4.5 SPINAL SYSTEMS
- K060748 — MODIFICATION TO XIA 4.5 SPINAL SYSTEM
- K060361 — XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM
- K053115 — XIA SPINAL SYSTEM
- K052971 — STRYKER SPINE TRIO SPINAL FIXATION SYSTEM
- K051205 — STRYKER SPINE AVS ASL PEEK SPACER
- K052761 — MODIFICATION TO: XIA 4.5 SPINAL SYSTEM
- K052317 — MODIFICATION TO: STRYKER SPINE OASYS SYSTEM
- K052181 — MODIFICATION TO XIA SPINAL SYSTEM
- K051973 — MODIFICATION TO: XIA STAINLESS STEEL SYSTEM
- K050461 — XIA 4.5 SPINAL SYSTEM
- K050624 — STRYKER SPINE AVS PL PEEK SPACER
- K043180 — STRYKER SPINE TRIO PS
- K050189 — TECHTONIX SYSTEM
- K042571 — STRYKER SPINE AVS TL PEEK SPACER
- K043473 — MODIFICATION TO XIA SPINAL SYSTEM
- K040731 — STRYKER SPINE VERTEBRAL SPACER
- K040261 — REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.