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Bipolar Head Trial Head

by Limacorporate 10 variants

Ref 9050.10.595Model Bipolar Head - Trial Head Dia.53mm, 80333902A015BM

Active European Union and United States. Also listed in GUDID (US).

CE MDR 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) K112158

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-08033390032490 Basic UDI-DI 08033390032490UDI-DIDate6 Nov 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08033390032490 Basic UDI-DI 08033390032490UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390032490 UDI-DI Date17 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK112158 Date10 May 2012DecidedStatusActive

Official records

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 7 Nov 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Bipolar Head - Trial Head Dia.53mm EUDAMED
Bipolar Head GUDID
Generic name
Acetabulum prosthesis trial, prefabricated, reusable
Model / Ref / Catalog
Bipolar Head - Trial Head Dia.53mm, 9050.10.595, 80333902A015BM, Trial Head
Primary DI / UDI-DI
08033390032490
Basic UDI-DI
B-08033390032490, 80333902A015BM
510(k) Number
FDA product code
LPH, KWZ, KWY, JDI
EMDN code
V06010101 Hip prostheses testing devices
GMDN term
Acetabulum prosthesis trial, prefabricated, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3358, 888.3310, 888.3390, 888.3350
EU registration type
Legacy device (under a directive)
Standard device
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
Bipolar Head - Trial Head Dia.53mm
9050.10.595
80333902A015BM
GUDID
Trial Head
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Acetabulum prosthesis trial, prefabricated, reusable

Cleared under the same submission (K112158)

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number

Other properties (21)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No