← Product Code [JDK](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JDK) · K030871

# FIDJI LARGE CEMENT RESTRICTOR (K030871)

_Spine Next SA · JDK · Dec 22, 2003 · General, Plastic Surgery · SESU_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDK/K030871

## Device Facts

- **Applicant:** Spine Next SA
- **Product Code:** [JDK](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JDK.md)
- **Decision Date:** Dec 22, 2003
- **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/K030871](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDK/K030871)

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