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Instrument Set Beater for Head Adaptors

by Limacorporate

Ref 9075.10.135Model SMR System - Beater For Head Adaptors

Instrument Set Beater for Head Adaptors (9075.10.135) is a device classified as Class I in the EU and Class II in the US made by Limacorporate, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-08033390046978), cleared under FDA 510(k) K100858 on 10 Dec 2010 and listed in FDA GUDID since 5 Aug 2016 (UDI-DI 08033390046978), active as of 7 Nov 2026. 2 FDA recalls are linked to it.

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 ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K100858

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-08033390046978 Basic UDI-DI 08033390046978UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390046978 UDI-DI Date5 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK100858 Date10 Dec 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08033390046978 registered 6 Nov 2026 Active
  • FDA 510(k) K100858 decided 10 Dec 2010 Active
  • FDA GUDID UDI-DI 08033390046978 listed 5 Aug 2016 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2539-2015 FDA Class II initiated 14 Aug 2015
    • Terminated Z-2540-2015 FDA Class II initiated 14 Aug 2015

    The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.

Timeline

5 dated events

  1. Cleared FDA 510(k) K100858
  2. Recall initiated FDA recalls Z-2539-2015
  3. Recall initiated FDA recalls Z-2540-2015
  4. Listed FDA GUDID 08033390046978
  5. Registered EUDAMED B-08033390046978

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  • Withdrawn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 System - Beater For Head Adaptors EUDAMED
Instrument Set GUDID
Generic name
Orthopaedic implant/instrument assembling device
Model / Ref / Catalog
SMR System - Beater For Head Adaptors, 9075.10.135, Beater for Head Adaptors
Primary DI / UDI-DI
08033390046978
Basic UDI-DI
B-08033390046978
510(k) Number
FDA product code
KWT, HSD
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic implant/instrument assembling device
Device class
Class I 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
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SMR System - Beater For Head Adaptors
9075.10.135
GUDID
Beater for Head Adaptors
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: Orthopaedic implant/instrument assembling device

Cleared under the same submission (K100858)

and 8 more cleared under K100858

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)