Ltm-T Surgical Mesh

FDA 510(k)

Class II (US FDA 510(k))

510(k) K080353

Identifiers

510(k) Number: K080353 FDA 510(k)
FDA Product Code: FTL 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)

The Ltm-T Surgical Mesh is a surgical mesh derived from porcine skin, used for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery. It consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses. The device is packaged in a double pouch configuration.

The Ltm-T Surgical Mesh is supplied in various configurations and is intended for single-use. It is regulated under the product code FTL and regulation number 878.3300. The device has been cleared by the FDA under the 510(k) clearance type, with the decision code SESE, and is manufactured by Lifecell Corp.

Frequently asked questions

What is the LTM-T Surgical Mesh made of?

The LTM-T Surgical Mesh is derived from porcine skin, specifically a processed porcine dermal matrix.

Is the LTM-T Surgical Mesh sterilized?

Yes, the LTM-T Surgical Mesh is terminally sterilized and provided in a double pouch configuration.

Is the LTM-T Surgical Mesh intended for single or multiple uses?

The LTM-T Surgical Mesh is intended for single-use only.

What are the available configurations of the LTM-T Surgical Mesh?

The LTM-T Surgical Mesh is supplied in various geometric configurations and thicknesses.

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-T SURGICAL MESH (K080353) — FDA 510 (k) | Innolitics, PDF 510(K) SUMMARY LifeCell Corporation's LTM Surgical Mesh 3 2008, LRTM SURGICAL MESH (K070560) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K080353	Class II	Active

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Manufacturer

Manufacturer: Lifecell Corp.

Sources (1)

FDA 510(k) K080353 24 fields · synced Sep 27, 2026