← Product Code [JDQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ) · K970084

# LINK CERCLAGE WIRE SYSTEM (K970084)

_Turnkey Intergration USA, Inc. · JDQ · Mar 13, 1997 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K970084

## Device Facts

- **Applicant:** Turnkey Intergration USA, Inc.
- **Product Code:** [JDQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ.md)
- **Decision Date:** Mar 13, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3010
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K970084](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K970084)

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