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Trigen Max 72502036

by Smith & Nephew, Inc.

Part of a family of 11 devices: see the family page

Ref 72502036

Trigen Max 72502036 is a device classified as Class I in the EU and Class II in the US made by Smith & Nephew, Inc., registered in EUDAMED on 21 Sep 2026 (Basic UDI-DI 0885556SN000357MA), cleared under FDA 510(k) K240061 on 20 Sep 2024 and listed in FDA GUDID since 7 May 2025 (UDI-DI 00885556896037), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240061

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0885556SN000357MA Basic UDI-DI 00885556896037UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00885556896037 UDI-DI Date7 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK240061 Date20 Sep 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0885556SN000357MA registered 21 Sep 2026 Active
  • FDA 510(k) K240061 decided 20 Sep 2024 Active
  • FDA GUDID UDI-DI 00885556896037 listed 7 May 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K240061
  2. Listed FDA GUDID 00885556896037
  3. Registered EUDAMED 0885556SN000357MA

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Trigen Max
Generic name
Surgical drill guide, reusable
Device name
Memphis Class IR SNOI-TF-026 L091199
Model / Ref / Catalog
72502036
Primary DI / UDI-DI
00885556896037
Basic UDI-DI
0885556SN000357MA
510(k) Number
FDA product code
HSB
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Surgical drill guide, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3020
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical drill guide, reusable

Cleared under the same submission (K240061)

and 8 more cleared under K240061

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)