Panels › Orthopedic › Product code PEK · Class 2
Spinous Process Plate
Regulation 888.3050
2510(k)s in 12 months (49 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PEK
| Company | 510(k)s | Recalls |
|---|---|---|
| Spinal Simplicity | 11 | 0 |
| Aurora Spine | 4 | 0 |
| Globus Medical, Inc. | 3 | 0 |
| Precision Spine, Inc. | 3 | 0 |
| Dio Medical Co., Ltd. | 2 | 0 |
| Nu Vasive, Incorporated | 2 | 0 |
| Nuvasive, Inc. | 2 | 0 |
| Paradigm Spine GmbH | 2 | 0 |
| Amplio Spine, LLC | 1 | 0 |
| Innovasis, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2021 | XTANT Medical X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. Terminated |
PEK | K130438 |
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