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Humeris Shoulder 911-1004

by Fx Solutions

Part of a family of 19 devices: see the family page

Ref 911-1004

Humeris Shoulder 911-1004 is a device classified as Class IIa in the EU and Class II in the US made by Fx Solutions, registered in EUDAMED on 19 Jun 2026 (Basic UDI-DI 37010373TRIAGLFL), cleared under FDA 510(k) K163669 on 17 May 2017 and listed in FDA GUDID since 22 May 2017 (UDI-DI 03701037304419), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163669

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number37010373TRIAGLFL Basic UDI-DI 03701037304419UDI-DIDate19 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03701037304419 UDI-DI Date22 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK163669 Date17 May 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 37010373TRIAGLFL registered 19 Jun 2026 Active
  • FDA 510(k) K163669 decided 17 May 2017 Active
  • FDA GUDID UDI-DI 03701037304419 listed 22 May 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K163669
  2. Listed FDA GUDID 03701037304419
  3. Registered EUDAMED 37010373TRIAGLFL

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  • Withdrawn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
Humeris Shoulder
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device name
Trial Glenoid
Model / Ref / Catalog
911-1004
Primary DI / UDI-DI
03701037304419
Basic UDI-DI
37010373TRIAGLFL
Direct marketing DI
03701037304419
510(k) Number
FDA product code
HSD
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3690
EU registration type
Standard device
EU market of registration
France
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 IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Orthopaedic surgical procedure kit, non-medicated, reusable

Cleared under the same submission (K163669)

and 8 more cleared under K163669

Similar devices in this category

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

Other devices from Fx Solutions

See all devices from Fx Solutions →

Properties

  • Sterilise before use
  • Reusable
Other properties (23, all answered No)