38 results
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7ms
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Sources: EU EUDAMED, US FDA
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
FDA Enforcement
Class II
·Terminated·I-Flow LLC·June 12, 2013
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
FDA Enforcement
Class II
·Terminated·I-Flow LLC·June 12, 2013
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
5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012