136 results
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9ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·September 5, 2012
7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009