Modification to the Bioplate Bioclip Craniotomy Fixation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K011380 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 Modification to the Bioplate Bioclip Craniotomy Fixation System is a bone plate device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.
This device is supplied as a modification to an existing system and is classified as a Class 2 medical specialty device under regulation 872.4760. It received FDA 510(k) clearance on May 14, 2001, with the product code JEY and is reviewed by the Dental panel. The device is intended for dental applications and is supplied in various sizes as indicated by the multiple registration numbers provided.
Frequently asked questions
What is the Bioplate Bioclip Craniotomy Fixation System used for?
The Bioplate Bioclip Craniotomy Fixation System is a bone plate device designed to stabilize fractured bone structures in the oral cavity. It works by attaching bone segments to the plate with screws to prevent movement of the segments, providing stability during the healing process.
How is the Bioplate Bioclip Craniotomy Fixation System supplied?
This device is supplied as a modification to an existing system and is available in various sizes to accommodate different patient needs. The multiple registration numbers indicate the range of sizes and configurations available for dental applications.
What is the regulatory status of the Bioplate Bioclip Craniotomy Fixation System?
The device is classified as a Class 2 medical specialty device under regulation 872.4760. It received FDA 510(k) clearance on May 14, 2001, with the product code JEY and is reviewed by the Dental panel, indicating it meets the safety and effectiveness requirements for dental applications.
Is the Bioplate Bioclip Craniotomy Fixation System reusable or single-use?
The device information does not specify whether it is designed for single-use or multiple uses. As a surgical implant intended to stabilize bone structures, it would typically be implanted during a procedure and remain in place during the healing process, but the specific reuse policy would depend on the manufacturer's instructions and clinical guidelines.
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: Modification to The Bioplate Bioclip Craniotomy Fixation System, MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM by ..., MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM 510 (k ..., Modification to The Bioplate Bioclip Craniotomy Fixation System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011380 | Class II | Active |
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Manufacturer
- Manufacturer
- Bioplate, Inc.
Sources (1)
- FDA 510(k) K011380 24 fields · synced Sep 25, 2026