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Mpact Acetabular System 01.32.4055

by Medacta International

Ref 01.32.4055

Mpact Acetabular System 01.32.4055 is a device classified as Class III in the EU and Class II in the US made by Medacta International, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-07630030812293), cleared under FDA 510(k) K122641 on 28 Sep 2012 and listed in FDA GUDID since 18 Nov 2014 (UDI-DI 07630030812293), 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) K122641

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-07630030812293 Basic UDI-DI 07630030812293UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630030812293 UDI-DI Date18 Nov 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK122641 Date28 Sep 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07630030812293 registered 30 Oct 2026 Active
  • FDA 510(k) K122641 decided 28 Sep 2012 Active
  • FDA GUDID UDI-DI 07630030812293 listed 18 Nov 2014 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K122641
  2. Listed FDA GUDID 07630030812293
  3. Registered EUDAMED B-07630030812293

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  • Withdrawn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
Cortical bone screw flat head Ø 4 L 55 EUDAMED
Mpact Acetabular System GUDID
Generic name
Orthopaedic bone screw, non-bioabsorbable, sterile
Device name
Hip Cortical Screw
Model / reference
01.32.4055
Primary DI / UDI-DI
07630030812293
Basic UDI-DI
B-07630030812293
510(k) Number
FDA product code
LZO, LPH
EMDN code
P09120601 Cortical screws
GMDN term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3353, 888.3358
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
Device classEUDAMED
Class III
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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: Orthopaedic bone screw, non-bioabsorbable, sterile

Cleared under the same submission (K122641)

and 8 more cleared under K122641

Similar devices in this category

Other devices filed under CORTICAL SCREWS.

Other devices from Medacta International

See all devices from Medacta International →

Properties

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