Depuy Spine, Inc.
Depuy Spine, Inc. holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2020, with 36 FDA device recalls on record.
Top product codes for Depuy Spine, Inc.
FDA recalls by Depuy Spine, Inc.
10 most recent of 36- Z-1323-2022 — EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD). Part Number: CUI8060L
- Z-1324-2022 — EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) Part Number: CUI8070S
- Z-1226-2019 — Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)
- Z-1225-2019 — Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
- Z-1300-2018 — Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).
- Z-0625-2017 — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186852018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy.
- Z-0630-2017 — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item Code: 186864018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy.
- Z-0624-2017 — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186850018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy.
- Z-0626-2017 — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy.
- Z-0629-2017 — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy.
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 Depuy Spine, Inc.
- K201831 — CONFIDENCE Spinal Cement System
- K142185 — EXPEDIUM VERSE SPINE SYSTEM
- K111136 — EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
- K121020 — VIPER SYSTEM
- K110353 — MOUNTAINEER OCT SPINAL SYSTEM
- K110216 — EXPEDIUM SYSTEM, VIPER SYSTEM
- K103133 — VEPER SYSTEM, EXPEDIUM SYSTEM
- K101993 — VIPER SYSTEM, EXPEDIUM SYSTEM
- K103100 — MOUNTAINEER OCT SPINAL SYSTEM
- K101762 — VIPER F2 FACET FIXATION SYSTEM
- K102701 — VIPER SPINE SYSTEM
- K101933 — MODIFICATION TO:EXPEDIUM SPINE SYSTEM
- K093390 — HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025
- K100070 — UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
- K091994 — MOUNTAINEER LAMINOPLASTY SYSTEM
- K092473 — EXPEDIUM SPINE SYSTEM
- K092626 — MODIFICATION TO: EXPEDIUM SPINE SYSTEM
- K090648 — VIPER 2 SYSTEM
- K081917 — DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS
- K090899 — DEPUY SPINE LATERAL SYSTEM
- K090799 — MODIFICATION TO EXPEDIUM SPINE SYSTEM
- K090230 — EXPEDIUM SPINE SYSTEM
- K082942 — MODFICATION TO: EXPEDIUM SPINE SYSTEM
- K081898 — EXPEDIUM SPINE SYSTEM
- K082273 — UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
- K081758 — HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015
- K082195 — MODIFICATIONS TO EXPEDIUM SPINE SYSTEM
- K081432 — HEALOS II BONE GRAFT SUBSTITUTE
- K080828 — MOUNTAINEER OCT SPINAL SYSTEM
- K081252 — EXPEDIUM 4.5MM SPINE SYSTEM
- K073562 — MODIFICATION TO VIPER SPINE SYSTEM
- K080313 — MODIFICATION TO EXPEDIUM SPINE SYSTEM
- K080568 — X-MESH EXPANDABLE CAGE SYSTEM
- K073364 — EXPEDIUM 4.5MM SPINE SYSTEM
- K080191 — EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM
- K073649 — BENGAL STACKABLE CAGE SYSTEM
- K073126 — EXPEDIUM SPINE SYSTEM
- K072546 — SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM
- K070387 — EXPEDIUM SPINE SYSTEM
- K071860 — MODIFICATION TO: VIPER SPINE SYSTEM
- K063772 — EXPEDIUM SPINE SYSTEM
- K070994 — EAGLE + ANTERIOR CERVICAL PLATE SYSTEM
- K070300 — EXPEDIUM SFX CROSS CONNECTOR SYSTEM
- K063741 — EXPEDIUM SPINE SYSTEM
- K062814 — PIPELINE II ACCESS SYSTEM
- K063156 — MODIFICATION TO EXPEDIUM SPINE SYSTEM
- K062174 — MODIFICATION TO EXPEDIUM SPINE SYSTEM
- K062495 — HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM
- K062196 — SFX SNAP-FIT CROSS CONNECTOR
- K061520 — VIPER SPINE SYSTEM
- K052546 — AEGIS ANTERIOR LUMBAR PLATE SYSTEM
- K052746 — CONCORDE VBR SPINAL SYSTEM
- K052552 — HYBRID ANTERIOR CERVICAL PLATE SYSTEM
- K052131 — EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS
- K051296 — SIJF CANNULATED SCREW SYSTEM
- K043406 — VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
- K051024 — EXPEDIUM SPINE SYSTEM
- K050675 — EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE
- K043308 — MODIFICATION TO: HEALOS BONE GRAFT MATERIAL
- K042544 — UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
- K042508 — SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM
- K041722 — MODIFICATION TO VBR SPINAL SYSTEM
- K041801 — EXPEDIUM MIS SPINE SYSTEM
- K041205 — EXPEDIUM ANTERIOR SPINE SYSTEM
- K041119 — EXPEDIUM SPINE SYSTEM
- K040655 — SWIFT ANTERIOR CERVICAL PLATE SYSTEM
- K041203 — SUMMIT OCT SPINAL SYSTEM
- K033901 — MERLIN SPINE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.