Skip to content

Bipolar Head Femoral Head Gauge

by Limacorporate 3 variants

Ref 9050.10.002Model 80333902A049C6, Bipolar Head - Femoral Head Gauge Dia46-50

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/MDD EUDAMED Number80333902A049C6 Basic UDI-DI 08033390032155UDI-DIDate29 Oct 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number80333902A049C6 Basic UDI-DI 08033390032155UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390032155 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  • Withdrawn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/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Bipolar Head - Femoral Head Gauge Dia46-50 EUDAMED
Bipolar Head GUDID
Generic name
Surgical implant template, reusable
Model / Ref / Catalog
80333902A049C6, 9050.10.002, Bipolar Head - Femoral Head Gauge Dia46-50, Femoral Head Gauge
Primary DI / UDI-DI
08033390032155
Basic UDI-DI
80333902A049C6, B-08033390032155
510(k) Number
FDA product code
JDI, KWY, KWZ, LPH
EMDN code
V030201 Calipers
GMDN term
Surgical implant template, reusable
Device class
Class IIa EUDAMED
Class I EUDAMED
Class II GUDID
Regulation number
888.3350, 888.3390, 888.3310, 888.3358
EU registration type
Standard device
Legacy device (under a directive)
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
80333902A049C6
9050.10.002
Bipolar Head - Femoral Head Gauge Dia46-50
GUDID
Femoral Head Gauge
Device classEUDAMED
Class IIa
Class I
GUDID
Class II

Related devices

Category: Surgical implant template, reusable

Cleared under the same submission (K112158)

Show all (12)

Other devices from Limacorporate

See all devices from Limacorporate →

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