Fastener, Plate, Cranioplasty
The Cranioplasty Plate Fastener is an implanted hardware component used to secure cranioplasty plates to the skull following reconstruction of cranial defects, maintaining plate position and providing structural stability during healing. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification, and is designated as an implant. The product code is HBW under regulation 21 CFR 882.5360 in the Neurology specialty. The implant flag is active for this device.
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Basic Information
- Product Code
- HBW
- Device Class
- FDA class 2
- Regulation Number
- 882.5360
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System | Jul 11, 2025 | Substantially Equivalent | Inion OY |
| K231208 | Stryker Resorbable Fixation System | Aug 14, 2023 | Substantially Equivalent | Stryker Leibinger GmbH & Co KG |
| K171152 | Stryker Universal Neuro III System AXS Screw | May 19, 2017 | Substantially Equivalent | Stryker |
| K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade | Jun 24, 2015 | Substantially Equivalent | Stryker |
| K141385 | DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) | Mar 27, 2015 | Substantially Equivalent | Depuy Synthes Companies of Johnson & Johnson |
| K101835 | MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 | Dec 03, 2010 | Substantially Equivalent | Porex Surgical, Inc. |
| K001353 | MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM | Mar 13, 2001 | Substantially Equivalent | Biomedical Ent., Inc. |
FEI Numbers
This FDA classification entry is associated with 34 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.