← Product Code [JDK](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JDK) · K010528

# TITANIUM CEMENT RESTRICTOR MATERIAL PEEK (K010528)

_Medtronic Sofamor Danek USA, Inc. · JDK · Oct 10, 2001 · General, Plastic Surgery · SESU_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDK/K010528

## Device Facts

- **Applicant:** Medtronic Sofamor Danek USA, Inc.
- **Product Code:** [JDK](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JDK.md)
- **Decision Date:** Oct 10, 2001
- **Decision:** SESU
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.3300
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDK/K010528](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDK/K010528)

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