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MBO101

by Tornier, Inc.

Ref MBO101Model 370038690021PX2

MBO101 is a Class I device made by Tornier, Inc., registered in EUDAMED on 3 Aug 2026 (Basic UDI-DI 370038690021PX2) and listed in FDA GUDID since 8 Aug 2022 (UDI-DI 03700386958908), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number370038690021PX2 Basic UDI-DI 03700386958908UDI-DIDate3 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700386958908 UDI-DI Date8 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 370038690021PX2 registered 3 Aug 2026 Active
  • FDA GUDID UDI-DI 03700386958908 listed 8 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700386958908
  2. Registered EUDAMED 370038690021PX2

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Cement Restrictor
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
Cement Restrictor Instrumentation - Guiding Instrumentation - Class I - Reusable - Non Sterile
Model / Ref / Catalog
MBO101, 370038690021PX2
Primary DI / UDI-DI
03700386958908
Basic UDI-DI
370038690021PX2
Direct marketing DI
03700386958908
FDA product code
LXH
EMDN code
L091105 Cementation instruments, reusable
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under CEMENTATION INSTRUMENTS, REUSABLE.

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)