Fastener, Plate, Cranioplasty
FDA product code HBW · Class II (moderate risk) · 21 CFR 882.5360 · Neurology
7510(k) clearances
0PMA approvals
1recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable…HBW · Traditional | Inion OY | 07/11/2025SE |
| K231208 | Stryker Resorbable Fixation SystemHBW · Traditional | Stryker Leibinger GmbH & Co KG | 08/14/2023SE |
| K171152 | Stryker Universal Neuro III System AXS ScrewHBW · Special | Stryker | 05/19/2017SE |
| K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeHBW · Special | Stryker | 06/24/2015SE |
| K141385 | Depuy Synthes Injectable Polymer System (Ips)HBW · Traditional | Depuy Synthes Companies of Johnson & Johnson | 03/27/2015SE |
| K101835 | Medpor Fixation System-Cranial, Models 80080, 80079HBW · Traditional | Porex Surgical, Inc. | 12/03/2010SE |
| K001353 | Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for…HBW · Traditional | Biomedical Ent., Inc. | 03/13/2001SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1238-2024 Class II | RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair…Products not sterilized, sterility cannot be confirmed | Synthes (USA) Products LLC | 01/24/2024Open, Classified |