Reprocessed External Fixation Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K081586 FDA 510(k)
- FDA Product Code
- KTT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Reprocessed External Fixation Device is a medical device intended for use in the construction of an external fixation frame. It is utilized for the treatment of various fracture types.
This device is supplied by Sterilmed, Inc. and has received FDA 510k clearance under K081586. It is designed to be used in conjunction with sterile bone pins and Kirschner wires.
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: REPROCESSED EXTERNAL FIXATION DEVICE (K051957) — FDA 510 (k) | Innolitics, Reprocessed External Fixation Device 510 (k) FDA Premarket Notification ..., REPROCESSED EXTERNAL FIXATION DEVICE (K081586) — FDA 510 (k) | Innolitics, Reprocessed External Fixation Accessories 510 (k) FDA Premarket ..., PDF K081586 - Reprocessed External Fixation Device
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081586 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterilmed, Inc.
Sources (1)
- FDA 510(k) K081586 24 fields · synced Sep 25, 2026