← Product Code [LZN](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZN) · K955751

# PRIME FEMORAL CEMENT PLUG (K955751)

_Orthopaedic Innovations, Inc. · LZN · Jan 26, 1996 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZN/K955751

## Device Facts

- **Applicant:** Orthopaedic Innovations, Inc.
- **Product Code:** [LZN](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/LZN.md)
- **Decision Date:** Jan 26, 1996
- **Decision:** SESE
- **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/LZN/K955751](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZN/K955751)

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