FDA Product Code
FDA Product Code HBW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5360
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System | Inion OY | 2025-07-11 | Traditional | PDF ↗ |
| K231208 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | 2023-08-14 | Traditional | PDF ↗ |
| K171152 | Stryker Universal Neuro III System AXS Screw | Stryker | 2017-05-19 | Special | PDF ↗ |
| K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade | Stryker | 2015-06-24 | Special | PDF ↗ |
| K141385 | DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) | Depuy Synthes Companies of Johnson & Johnson | 2015-03-27 | Traditional | PDF ↗ |
| K101835 | MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 | Porex Surgical, Inc. | 2010-12-03 | Traditional | PDF ↗ |
| K001353 | MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM | Biomedical Ent., Inc. | 2001-03-13 | Traditional | PDF ↗ |
Product code HBW · Class II · Neurology. Data: openFDA.