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REVISION HIP - Ti6Al4V

by Limacorporate 16 variants

Ref 3812.15.010Model REVISION HIP

REVISION HIP - Ti6Al4V (3812.15.010) is a device classified as Class III in the EU and Class II in the US made by Limacorporate, registered in EUDAMED on 29 May 2026 (Basic UDI-DI B-08033390003865), cleared under FDA 510(k) K151739 on 23 Nov 2015 and listed in FDA GUDID since 6 May 2016 (UDI-DI 08033390003865), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K151739

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08033390003865 Basic UDI-DI 08033390003865UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390003865 UDI-DI Date6 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK151739 Date23 Nov 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08033390003865 registered 29 May 2026 Active
  • FDA 510(k) K151739 decided 23 Nov 2015 Active
  • FDA GUDID UDI-DI 08033390003865 listed 6 May 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K151739
  2. Listed FDA GUDID 08033390003865
  3. Registered EUDAMED B-08033390003865

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  • Withdrawn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
Revision Hip - Uncemented Stem D.16 Mm L.140 Mm EUDAMED
Revision GUDID
Generic name
Revision uncoated femoral stem prosthesis
Model / Ref / Catalog
REVISION HIP, 3812.15.010, REVISION HIP - Ti6Al4V
Primary DI / UDI-DI
08033390003865
Basic UDI-DI
B-08033390003865
510(k) Number
FDA product code
KWY, LPH, LZO
EMDN code
P090804030202 Revision uncemented femoral stems, with modular neck
GMDN term
Revision uncoated femoral stem prosthesis
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3390, 888.3358, 888.3353
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
Model / referenceEUDAMED
REVISION HIP
3812.15.010
GUDID
REVISION HIP - Ti6Al4V
Device classEUDAMED
Class III
GUDID
Class II

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: Revision uncoated femoral stem prosthesis

Cleared under the same submission (K151739)

and 8 more cleared under K151739

Similar devices in this category

Other devices filed under REVISION UNCEMENTED FEMORAL STEMS.

Other devices from Limacorporate

See all devices from Limacorporate →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)