Rod, Fixation, Intramedullary And Accessories
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K951673 FDA 510(k)
- FDA Product Code
- HSB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3020 FDA 510(k)
- Regulation Number
- 888.3020 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rod, Fixation, Intramedullary and Accessories is an orthopedic device designed for internal fixation. It functions as an intramedullary rod to provide structural support and stabilization for bone fractures.
This device is identified under product code HSB and is classified as a Class II medical device subject to special controls. It received FDA 510(k) clearance under K951673 on July 6, 1995.
Frequently asked questions
What is the primary clinical purpose of this fixation rod?
This device is designed for internal orthopedic fixation. It functions as an intramedullary rod to provide necessary structural support and stabilization for patients suffering from bone fractures.
What is the regulatory status of this device?
The device is classified as a Class II medical device subject to special controls. It received FDA 510(k) clearance on July 6, 1995, under the submission number K951673, confirming it is substantially equivalent to legally marketed predicate devices.
Under which product category is this device filed?
This device is identified under product code HSB and falls under the oversight of the Orthopedic advisory committee, which reviews submissions for internal fixation hardware.
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: K951673 - ROD | FDA 510 (k) | Acu Med, Inc., Rod, Fixation, Intramedullary and Accessories, K951740 FDA 510(k) - INTRAMEDULARY FIXATION ROD | Acu Med, Inc., K951673 - ROD | FDA 510 (k) | Acu Med, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K951673 | Class II | Active |
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Manufacturer
- Manufacturer
- Acu Med, Inc.
Sources (1)
- FDA 510(k) K951673 24 fields · synced Sep 21, 2026