Identifiers
- 510(k) Number
- K141053 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)
Ovine Tissue Matrix (OTM) is a surgical mesh device composed of ovine-derived extracellular matrix, specifically collagen I and III, combined with polypropylene. It functions as a scaffold intended for soft tissue repair.
This device is supplied sterile and ready-to-use, requiring no rehydration before application. It has received FDA 510(k) clearance.
Frequently asked questions
What is the Ovine Tissue Matrix (OTM) used for?
The Ovine Tissue Matrix (OTM) is intended for use as a surgical scaffold for soft tissue repair. It combines ovine-derived extracellular matrix, specifically collagen I and III, with polypropylene to provide structural support during the repair process.
How is the Ovine Tissue Matrix supplied?
The device is supplied in a sterile, ready-to-use format. It does not require any rehydration or additional preparation steps before it is applied by the surgeon.
What is the regulatory status of this device?
The Ovine Tissue Matrix (OTM) has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices for its intended use.
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: TELA Bio | Surgical Reconstruction Company, OVINE TISSUE MATRIX(OTM) (K141053) — FDA 510(k) | Innolitics, Hernia Repair & Ab Wall Reconstruction | TELA Bio
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141053 | Class II | Active |
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Manufacturer
- Manufacturer
- TELA Bio, Inc.
Sources (1)
- FDA 510(k) K141053 24 fields · synced Sep 26, 2026