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Trigen XT001162-1

by Smith & Nephew, Inc.

Trigen XT001162-1 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K040929 on 25 May 2004 and listed in FDA GUDID since 11 Oct 2021 (UDI-DI 00885556815274), 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) K040929

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 Number00885556815274 UDI-DI Date11 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK040929 Date25 May 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K040929 decided 25 May 2004 Active
  • FDA GUDID UDI-DI 00885556815274 listed 11 Oct 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K040929
  2. Listed FDA GUDID 00885556815274

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Trigen
Generic name
Femur intramedullary nail
Model / Ref / Catalog
XT001162-1
Primary DI / UDI-DI
00885556815274
510(k) Number
FDA product code
HSB
GMDN term
Femur intramedullary nail
Device class
Class II
Regulation number
888.3020
GUDID distribution status
In Commercial Distribution

Related devices

Category: Femur intramedullary nail

Cleared under the same submission (K040929)

and 8 more cleared under K040929

Similar devices in this category

Other devices filed under Femur intramedullary nail.

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

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