Sterile Radiolucent Skull Pins
FDA 510(k)Class II (US FDA 510(k))
by Brainlab AG
Identifiers
- 510(k) Number
- K122225 FDA 510(k)
- FDA Product Code
- HBL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4460 FDA 510(k)
- Regulation Number
- 882.4460 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sterile Radiolucent Skull Pins are part of a fixation system that provides rigid immobilization of the patient's skull during surgery. They are made of Carbon-Fiber Reinforced PEEK and are designed to penetrate the skull tabula externa to provide rigid fixation to compatible head-holder units. The device is classified as a Holder, Head, Neurosurgical (Skull Clamp).
The Sterile Radiolucent Skull Pins are single-use and used in hospital environments by physicians during neurosurgical procedures, such as craniotomy. They are supplied sterile and are authorized under FDA 510(k) with the clearance number K122225. The device is regulated under the regulation number 882.4460.
Frequently asked questions
What are Sterile Radiolucent Skull Pins used for?
These pins are part of a fixation system that provides rigid immobilization of the patient's skull during neurosurgical procedures such as craniotomy. They penetrate the skull tabula externa to secure compatible head-holder units.
Are the Sterile Radiolucent Skull Pins reusable?
No, these skull pins are designed for single-use only. They are supplied sterile and should not be reused to ensure patient safety and maintain sterility during neurosurgical procedures.
What material are the Sterile Radiolucent Skull Pins made from?
The pins are constructed from Carbon-Fiber Reinforced PEEK, a radiolucent material that allows for clear imaging during surgical procedures while providing the necessary rigidity for skull fixation.
What is the regulatory status of these skull pins?
The Sterile Radiolucent Skull Pins are authorized under FDA 510(k) with clearance number K122225. They are classified as a Holder, Head, Neurosurgical (Skull Clamp) and regulated under number 882.4460.
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: STERILE RADIOLUCENT SKULL PINS (K122225) — FDA 510(k) | Innolitics, PDF APR 62013 A - Food and Drug Administration, 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 | K122225 | Class II | Active |
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Manufacturer
- Manufacturer
- Brainlab AG
Sources (1)
- FDA 510(k) K122225 24 fields · synced Sep 24, 2026