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Tenoglide® TG221

by Integra Lifesciences Corp.

Tenoglide® TG221 is a Class II device made by Integra Lifesciences Corp., cleared under FDA 510(k) K053655 on 3 Feb 2006 and listed in FDA GUDID since 23 Sep 2015 (UDI-DI 10381780032441), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K053655

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780032441 UDI-DI Date23 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK053655 Date3 Feb 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K053655 decided 3 Feb 2006 Active
  • FDA GUDID UDI-DI 10381780032441 listed 23 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K053655
  2. Listed FDA GUDID 10381780032441

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tenoglide®
Generic name
Tendon spacer
Model / Ref / Catalog
TG221
Primary DI / UDI-DI
10381780032441
510(k) Number
FDA product code
FTM
GMDN term
Tendon spacer
Device class
Class II
Regulation number
878.3300
GUDID distribution status
In Commercial Distribution
Size
Length — 5 Centimeter
Width — 2 Inch
Length — 2 Inch
Width — 5 Centimeter

Related devices

Category: Tendon spacer

Cleared under the same submission (K053655)

Similar devices

Other devices filed under FDA product code FTM (Mesh, surgical).

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)