HBW
7 FDA 510(k) clearances · Product code
109 daysmedian time to decision
319 days90th percentile
7clearances measured
FDA profile
- Official device name
- Fastener, Plate, Cranioplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5360
- Medical specialty
- Neurology
- Flags
- Implant
- Adverse events (MAUDE)
- 1997: 1 · 2017: 14 · 2018: 22 · 2019: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System (K251472) | Inion OY | 2025-07-11 |
| Stryker Resorbable Fixation System (K231208) | Stryker Leibinger GmbH & Co KG | 2023-08-14 |
| Stryker Universal Neuro III System AXS Screw (K171152) | Stryker | 2017-05-19 |
| Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade (K151387) | Stryker | 2015-06-24 |
| DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) (K141385) | Depuy Synthes Companies of Johnson & Johnson | 2015-03-27 |
| MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 (K101835) | Porex Surgical, Inc. | 2010-12-03 |
| MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM (K001353) | Biomedical Ent., Inc. | 2001-03-13 |
Track HBW automatically
Every clearance here is in the API, with alerts when new ones post.