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SMR Shoulder Humeral Head (CoCrMo)

by Limacorporate 46 variants

Ref 1325.09.541Model SMR SHOULDER - HUMERAL HEAD DIA. 54 MM H. 24 MM

SMR Shoulder Humeral Head (CoCrMo) (1325.09.541) is a device classified as Class III in the EU and Class II in the US made by Limacorporate, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-08033390116626), cleared under FDA 510(k) K161476 on 24 Jun 2016 and listed in FDA GUDID since 7 Jul 2016 (UDI-DI 08033390116626), active as of 7 Nov 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K161476

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08033390116626 Basic UDI-DI 08033390116626UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390116626 UDI-DI Date7 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK161476 Date24 Jun 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08033390116626 registered 6 Nov 2026 Active
  • FDA 510(k) K161476 decided 24 Jun 2016 Active
  • FDA GUDID UDI-DI 08033390116626 listed 7 Jul 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K161476
  2. Listed FDA GUDID 08033390116626
  3. Registered EUDAMED B-08033390116626

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Smr Shoulder - Humeral Head Dia. 54 Mm H. 24 Mm EUDAMED
SMR Shoulder GUDID
Generic name
Coated shoulder humeral stem prosthesis
Model / Ref / Catalog
SMR SHOULDER - HUMERAL HEAD DIA. 54 MM H. 24 MM, 1325.09.541, Humeral Head (CoCrMo)
Primary DI / UDI-DI
08033390116626
Basic UDI-DI
B-08033390116626
510(k) Number
FDA product code
KWT, HSD
EMDN code
P090104010101 Epiphysary humeral components for anatomical prostheses - humeral heads
GMDN term
Coated shoulder humeral stem prosthesis
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3650, 888.3690
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SMR SHOULDER - HUMERAL HEAD DIA. 54 MM H. 24 MM
1325.09.541
GUDID
Humeral Head (CoCrMo)
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Coated shoulder humeral stem prosthesis

Cleared under the same submission (K161476)

and 8 more cleared under K161476

Similar devices in this category

Other devices filed under EPIPHYSARY HUMERAL COMPONENTS FOR ANATOMICAL PROSTHESES - HUMERAL HEADS.

Other devices from Limacorporate

See all devices from Limacorporate →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)