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The Bioplate Rigid Fixation Bone Plating System For Craniomaxillofacial Surgery
FDA 510(k)Class II (US FDA 510(k))
510(k) K031028
Identifiers
- 510(k) Number
- K031028 FDA 510(k)
- FDA Product Code
- JEY 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 BioPlate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is a highly effective and innovative solution for surgical implantation, providing stable and secure bone fixation in complex craniofacial procedures. This system is designed to offer optimal results with minimal complications, making it an essential tool for orthopedic surgeons and maxillofacial specialists.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K031028 | Class II | Active |
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Manufacturer
- Manufacturer
- Bioplate, Inc.
Sources (1)
- FDA 510(k) K031028 24 fields · synced Jul 7, 2026