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
- 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 Bioabsor | July 11, 2025 |
| K231208 | stryker leibinger gmbh and co kg | Stryker Resorbable Fixation System | August 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 Bla | June 24, 2015 |
| K141385 | depuy synthes companies of johnson and johnson | DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) | March 27, 2015 |
| K101835 | porex surgical | MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 | December 3, 2010 |
| K001353 | biomedical ent | MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPL | March 13, 2001 |