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Corin BiPolar-i 1110958

by Corin Ltd

Ref 1110958Model BiPolar-i

Corin BiPolar-i 1110958 is a device classified as Class IIb in the EU and Class II in the US made by Corin Ltd, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-05056139234491), cleared under FDA 510(k) K183114 on 5 Jun 2019 and listed in FDA GUDID since 16 Jul 2019 (UDI-DI 05056139234491), active as of 24 Oct 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183114

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05056139234491 Basic UDI-DI 05056139234491UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05056139234491 UDI-DI Date16 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183114 Date5 Jun 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05056139234491 registered 27 Oct 2026 Active
  • FDA 510(k) K183114 decided 5 Jun 2019 Active
  • FDA GUDID UDI-DI 05056139234491 listed 16 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183114
  2. Listed FDA GUDID 05056139234491
  3. Registered EUDAMED B-05056139234491

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  • Withdrawn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
Bipolar-i Ø58/28mm EUDAMED
Corin BiPolar-i GUDID
Generic name
Bipolar femoral head outer component, hemiarthroplasty
Device name
BiPolar-i for use in hip hemiarthroplasty
Model / Ref / Catalog
1110958, BiPolar-i
Primary DI / UDI-DI
05056139234491
Basic UDI-DI
B-05056139234491
510(k) Number
FDA product code
KWY
EMDN code
P090804050102 Metal femoral heads, partial hip replacement
GMDN term
Bipolar femoral head outer component, hemiarthroplasty
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3390
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 05056139234491: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIb 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: Bipolar femoral head outer component, hemiarthroplasty

Cleared under the same submission (K183114)

and 8 more cleared under K183114

Similar devices in this category

Other devices filed under METAL FEMORAL HEADS, PARTIAL HIP REPLACEMENT.

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)