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SMR Shoulder Stopper

by Limacorporate 2 variants

Ref 9013.75.751Model SMR Shoulder - Stopper SMALL-R, 80333902A045BW

SMR Shoulder Stopper (9013.75.751) is a device classified as Class I and Class IIa in the EU and Class II in the US made by Limacorporate, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-08033390091688), cleared under FDA 510(k) K110598 on 18 Aug 2011 and listed in FDA GUDID since 12 Apr 2016 (UDI-DI 08033390091688), active as of 7 Nov 2026. One FDA recall is linked to it.

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

CE MDR CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K110598

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/MDR EUDAMED NumberB-08033390091688 Basic UDI-DI 08033390091688UDI-DIDate6 Nov 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08033390091688 Basic UDI-DI 08033390091688UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390091688 UDI-DI Date12 Apr 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK110598 Date18 Aug 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08033390091688 registered 6 Nov 2026 Active· +1 more in the status table
  • FDA 510(k) K110598 decided 18 Aug 2011 Active
  • FDA GUDID UDI-DI 08033390091688 listed 12 Apr 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1711-2016 FDA Class II initiated 8 Apr 2016

    Complaints of intra-operative breakage of the glenosphere impactors/extractors.

Timeline

4 dated events

  1. Cleared FDA 510(k) K110598
  2. Recall initiated FDA recalls Z-1711-2016
  3. Listed FDA GUDID 08033390091688
  4. Registered EUDAMED B-08033390091688

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
SMR Shoulder - Stopper SMALL-R EUDAMED
SMR Shoulder GUDID
Generic name
Orthopaedic reamer guide
Model / Ref / Catalog
SMR Shoulder - Stopper SMALL-R, 9013.75.751, 80333902A045BW, Stopper
Primary DI / UDI-DI
08033390091688
Basic UDI-DI
B-08033390091688, 80333902A045BW
510(k) Number
FDA product code
KWS
EMDN code
L091199, L0922
GMDN term
Orthopaedic reamer guide
Device class
Class I EUDAMED
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3660
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SMR Shoulder - Stopper SMALL-R
9013.75.751
80333902A045BW
GUDID
Stopper
Device classEUDAMED
Class I
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class I and Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes.

Related devices

Category: Orthopaedic reamer guide

Cleared under the same submission (K110598)

and 8 more cleared under K110598

Similar devices in this category

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

Other devices from Limacorporate

See all devices from Limacorporate →

Properties

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