Fastener, Plate, Cranioplasty
Regulation 882.5360
0510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in HBW
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker | 2 | 0 |
| Biomedical Ent., Inc. | 1 | 0 |
| Depuy Synthes Companies of Johnson & Johnson | 1 | 0 |
| Inion OY | 1 | 0 |
| Porex Surgical, Inc. | 1 | 0 |
| Stryker Leibinger GmbH & Co KG | 1 | 0 |
| Synthes (USA) Products LLC | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2024 | Synthes (USA) Products LLC RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and Open, Classified |
HBW | K141385 |
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