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Mpact Double Mobility Shells 01.32.164MB

by Medacta International

Ref 01.32.164MB

Mpact Double Mobility Shells 01.32.164MB is a device classified as Class III in the EU and Class II in the US made by Medacta International, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-07630030861031), cleared under FDA 510(k) K143453 on 2 Mar 2015 and listed in FDA GUDID since 21 Sep 2015 (UDI-DI 07630030861031), 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) K143453

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-07630030861031 Basic UDI-DI 07630030861031UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630030861031 UDI-DI Date21 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK143453 Date2 Mar 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07630030861031 registered 28 Oct 2026 Active
  • FDA 510(k) K143453 decided 2 Mar 2015 Active
  • FDA GUDID UDI-DI 07630030861031 listed 21 Sep 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K143453
  2. Listed FDA GUDID 07630030861031
  3. Registered EUDAMED B-07630030861031

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  • Withdrawn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
Mpact DM Acetabular shell Ø64 EUDAMED
Mpact Double Mobility Shells GUDID
Generic name
Acetabular shell
Device name
Hip Mpact DM Acetabular Shell
Model / reference
01.32.164MB
Primary DI / UDI-DI
07630030861031
Basic UDI-DI
B-07630030861031
510(k) Number
FDA product code
LPH, LZO, MEH
EMDN code
P090803050102 Uncemented double-mobility acetabular cups
GMDN term
Acetabular shell
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3358, 888.3353
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Acetabular shell

Cleared under the same submission (K143453)

and 8 more cleared under K143453

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS.

Other devices from Medacta International

See all devices from Medacta International →

Properties

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