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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 11, 2025 | K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System Inion OY, FI | HBW |
| Aug 14, 2023 | K231208 | Stryker Resorbable Fixation System Stryker Leibinger GmbH & Co KG, DE | HBW |
| May 19, 2017 | K171152 | Stryker Universal Neuro III System AXS Screw Stryker | HBW |
| Jun 24, 2015 | K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade Stryker | HBW |
| Mar 27, 2015 | K141385 | DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) Depuy Synthes Companies of Johnson & Johnson | HBW |
| Dec 3, 2010 | K101835 | MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 Porex Surgical, Inc. | HBW |
| Mar 13, 2001 | K001353 | MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM Biomedical Ent., Inc. | HBW |
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