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XTAC Surgical Mesh

by Osteogenics, Inc.

510(k) K061934

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061934 Date17 Jul 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Xtac
510(k) Number
FDA Product Code
FTL
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

XTAC is a polymeric surgical mesh device intended for use in medical procedures. It is classified as a Class II medical device under the FDA's regulatory framework.

The device is supplied sterile and is intended for single-use applications. It is not MRI safe and should be stored in a controlled environment until use. The device has received FDA 510(k) clearance.

Other devices from Osteogenics Co.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the XTAC device used for?

    XTAC is a polymeric surgical mesh intended for use in medical procedures. It is classified as a Class II medical device.

  • Is the XTAC mesh device sterile and for single use?

    Yes, the XTAC mesh device is supplied sterile and is intended for single-use applications.

  • Can the XTAC mesh be used in an MRI environment?

    No, the XTAC mesh device is not MRI safe and should not be used in an MRI environment.

  • How should the XTAC mesh device be stored?

    The XTAC mesh device should be stored in a controlled environment until use.

  • What is the regulatory status of the XTAC mesh device?

    The XTAC mesh device has received FDA 510(k) clearance.