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MiniHip Stem 580.9063

by Corin Ltd

Ref 580.9063Model MiniHip Stem Instrument Set

MiniHip Stem 580.9063 is a device classified as Class I in the EU and Class II in the US made by Corin Ltd, registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI B-05055343880012), cleared under FDA 510(k) K083312 on 5 Apr 2010 and listed in FDA GUDID since 17 Aug 2016 (UDI-DI 05055343880012), 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) K083312

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-05055343880012 Basic UDI-DI 05055343880012UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055343880012 UDI-DI Date17 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK083312 Date5 Apr 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055343880012 registered 21 Oct 2026 Active
  • FDA 510(k) K083312 decided 5 Apr 2010 Active
  • FDA GUDID UDI-DI 05055343880012 listed 17 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K083312
  2. Listed FDA GUDID 05055343880012
  3. Registered EUDAMED B-05055343880012

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  • Withdrawn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
Starter Awl EUDAMED
MiniHip Stem GUDID
Generic name
Bone awl, reusable
Model / Ref / Catalog
580.9063, MiniHip Stem Instrument Set
Primary DI / UDI-DI
05055343880012
Basic UDI-DI
B-05055343880012
510(k) Number
FDA product code
LZO
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Bone awl, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3353
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Bone awl, reusable

Cleared under the same submission (K083312)

and 8 more cleared under K083312

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)