Identifiers
- 510(k) Number
- K931246 FDA 510(k)
- FDA Product Code
- JDQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3010 FDA 510(k)
- Regulation Number
- 888.3010 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A cerclage wire crimp sleeve is a device used in orthopedic procedures to secure cerclage wires around bone fragments or implants. It functions by crimping down onto the wire to provide a stable fixation point, aiding in the stabilization of fractures or osteotomies.
The device is supplied non-sterile and is intended for single use. It is manufactured by Acu Med, Inc. and received FDA 510(k) clearance (K931246) on February 22, 1994, under product code JDQ, with a traditional clearance pathway and no third-party review.
Frequently asked questions
What is the cerclage wire crimp sleeve used for?
The cerclage wire crimp sleeve is used in orthopedic procedures to secure cerclage wires around bone fragments or implants by crimping down onto the wire, providing a stable fixation point that aids in stabilizing fractures or osteotomies.
How is the cerclage wire crimp sleeve supplied and is it reusable?
The device is supplied non-sterile and is intended for single use only, meaning it should not be reprocessed or reused after initial application to ensure patient safety and device integrity.
Who manufactures the cerclage wire crimp sleeve and when was it cleared?
The cerclage wire crimp sleeve is manufactured by Acu Med, Inc. and received FDA 510(k) clearance (K931246) on February 22, 1994, under product code JDQ via a traditional clearance pathway with no third-party review.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K931246 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Acu Med, Inc.
Sources (1)
- FDA 510(k) K931246 24 fields · synced Sep 21, 2026