Identifiers
- 510(k) Number
- K071986 FDA 510(k)
- FDA Product Code
- FTM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3300 FDA 510(k)
- Regulation Number
- 878.3300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
LTM-RC Surgical Mesh is a soft tissue patch intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. The implant is intended for the reinforcement of soft tissues repaired by sutures or suture anchors, during rotator cuff surgery.
The device is supplied as a single-use implant and is intended for use in rotator cuff surgery, hernia repair, and body wall defects. The device is not sterilized and must be sterilized prior to use. The device is regulated as a Class II medical device under 21 CFR 878.3300.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LTM-RC SURGICAL MESH (K071986) — FDA 510(k) | Innolitics, PDF Ill. I 9 - Food and Drug Administration, Ltm-rc Surgical Mesh 510 (k) FDA Premarket Notification K071986 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071986 | Class II | Active |
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Manufacturer
- Manufacturer
- Lifecell Corp.
Sources (1)
- FDA 510(k) K071986 24 fields · synced Sep 22, 2026