HBW — Fastener, Plate, Cranioplasty Class II
FDA product code HBW covers "Fastener, Plate, Cranioplasty", a Class II medical device regulated under 21 CFR 882.5360. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HBW
- Device Class
- Class II
- Regulation Number
- 882.5360
- Submission Type
- 510(k)
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251472 | Inion | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby… | Jul 11, 2025 |
| K231208 | Stryker Leibinger Gmbh And Co Kg | Stryker Resorbable Fixation System | Aug 14, 2023 |
| K171152 | Stryker | Stryker Universal Neuro III System AXS Screw | May 19, 2017 |
| K151387 | Stryker | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver… | Jun 24, 2015 |
| K141385 | Depuy Synthes Companies Of Johnson And Johnson | DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) | Mar 27, 2015 |
| K101835 | Porex Surgical | MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 | Dec 3, 2010 |
| K001353 | Biomedical Ent | MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND… | Mar 13, 2001 |