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Mpact Acetabular System 01.32.6520

by Medacta International SA

Ref 01.32.6520

Mpact Acetabular System 01.32.6520 is a device classified as Class III in the EU and Class II in the US made by Medacta International SA, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-07630030812378), cleared under FDA 510(k) K103721 on 21 Mar 2011 and listed in FDA GUDID since 18 Nov 2014 (UDI-DI 07630030812378), active as of 12 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 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K103721

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07630030812378 Basic UDI-DI 07630030812378UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630030812378 UDI-DI Date18 Nov 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK103721 Date21 Mar 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07630030812378 registered 30 Oct 2026 Active
  • FDA 510(k) K103721 decided 21 Mar 2011 Active
  • FDA GUDID UDI-DI 07630030812378 listed 18 Nov 2014 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K103721
  2. Listed FDA GUDID 07630030812378
  3. Registered EUDAMED B-07630030812378

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  • Withdrawn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
Cancellous bone screw flat head Ø 6,5 L 20 EUDAMED
Mpact Acetabular System GUDID
Generic name
Orthopaedic bone screw, non-bioabsorbable, sterile
Device name
Hip Cancellous Bone Screw
Model / reference
01.32.6520
Primary DI / UDI-DI
07630030812378
Basic UDI-DI
B-07630030812378
510(k) Number
FDA product code
LZO, LPH
EMDN code
P09120602 Cancellous 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 (K103721)

and 8 more cleared under K103721

Similar devices in this category

Other devices filed under CANCELLOUS SCREWS.

Other devices from Medacta International SA

See all devices from Medacta International SA →

Properties

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