← Product Code [FTL](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL) · K000849

# SOFTFORM FACIAL IMPLANT (K000849)

_Tissue Technologies, Inc. · FTL · May 19, 2000 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL/K000849

## Device Facts

- **Applicant:** Tissue Technologies, Inc.
- **Product Code:** [FTL](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL.md)
- **Decision Date:** May 19, 2000
- **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/SU/subpart-d%E2%80%94prosthetic-devices/FTL/K000849](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL/K000849)

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