Modified Plate Design for Bioplate Zip Craniotomy Fixation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070901 FDA 510(k)
- FDA Product Code
- GXN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5330 FDA 510(k)
- Regulation Number
- 882.5330 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Modified Plate Design for Bioplate Zip Craniotomy Fixation System is a mechanical bone fixation device used in neurosurgical procedures. It consists of two circular caps in a parallel configuration connected by an internal, serrated post to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
The device is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants. The device has FDA 510(k) clearance with product code GXN and is classified as a Class II device.
Frequently asked questions
What is the primary purpose of the Modified Plate Design for Bioplate Zip Craniotomy Fixation System in neurosurgery?
This device is designed to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. It aligns and stabilizes bony tissue during the healing process, ensuring proper positioning while the bone regenerates.
Can this device be reused, or is it intended for single-use only?
The device is explicitly intended for single-use only, as stated in its description. This ensures sterility and safety for each patient procedure.
What materials are compatible for use with this fixation system?
The device is intended to be used only with other titanium or titanium alloy implants. This compatibility ensures mechanical stability and reduces the risk of adverse reactions.
How is the Modified Plate Design classified by regulatory authorities, and what does that mean for its use?
The device is classified as a Class II medical device by the FDA and has received 510(k) clearance under product code GXN. This classification means it is subject to special controls to ensure its safety and effectiveness, and it is regulated under the FDA’s premarket notification process.
What are the key features of the device’s design that help in craniotomy fixation?
The device consists of two circular caps connected by an internal, serrated post. The serrated post provides secure mechanical fixation, while the parallel configuration of the caps helps maintain proper alignment and stability of the cranial bone flap during healing.
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: modified eCommerce Shopsoftware - kostenloser OpenSource …, Mofication To: Modified Plate Design for Bioplate Zip Craniotomy ..., Modified Plate Design for Bioplate Zip Craniotomy Fixation System ..., Mofication To: Modified Plate Design for Bioplate Zip Craniotomy ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070901 | Class II | Active |
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Manufacturer
- Manufacturer
- Bioplate, Inc.
Sources (1)
- FDA 510(k) K070901 24 fields · synced Sep 19, 2026