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Trigen Max 72600834l

by Smith & Nephew, Inc.

Trigen Max 72600834l is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K240061 on 20 Sep 2024 and listed in FDA GUDID since 9 May 2025 (UDI-DI 00885556892596), 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) K240061

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 Number00885556892596 UDI-DI Date9 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK240061 Date20 Sep 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240061 decided 20 Sep 2024 Active
  • FDA GUDID UDI-DI 00885556892596 listed 9 May 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K240061
  2. Listed FDA GUDID 00885556892596

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Trigen Max
Generic name
Tibia intramedullary nail
Model / Ref / Catalog
72600834L
Primary DI / UDI-DI
00885556892596
510(k) Number
FDA product code
JDS
GMDN term
Tibia intramedullary nail
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Tibia intramedullary nail

Cleared under the same submission (K240061)

and 8 more cleared under K240061

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)