CRANION CRANIAL FIXATION SYSTEM - Fixlock
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051293 FDA 510(k)
- FDA Product Code
- JEY FDA 510(k)
- Models / Variants
- Cranion Cranial Fixation System FDA 510(k)Fixlock FDA 510(k)Cranial Solutions FDA 510(k)Ceremed Fixation System FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4760 FDA 510(k)
- Regulation Number
- 872.4760 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cranion Cranial Fixation System is a device intended for reconstruction of the craniomaxillofacial skeleton and for reattachment of cranial bone flaps after craniotomy procedures. It is used to align and stabilize bony tissue while normal healing occurs. Each implantable component is intended for single use only and may be combined only with other titanium and titanium alloy implants.
The system is supplied as a set of titanium and titanium alloy implants designed for single use. It is regulated under FDA 510(k) authorization with the product code JEY and is classified as a Class II device. The manufacturer is Ceremed, Inc., based in Los Angeles, CA, and the device is intended for use in dental and cranial surgical settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed ..., Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed ..., fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051293 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ceremed , Inc.
Sources (1)
- FDA 510(k) K051293 24 fields · synced Sep 25, 2026