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Unity Total Knee System CG000168

by Corin Ltd

Ref CG000168Model Unity Total Knee instrument set

Unity Total Knee System CG000168 is a device classified as Class IIa in the EU and Class II in the US made by Corin Ltd, registered in EUDAMED on 15 Oct 2026 (Basic UDI-DI B-05055343892626), cleared under FDA 510(k) K170808 on 13 Jul 2017 and listed in FDA GUDID since 18 Oct 2018 (UDI-DI 05055343892626), 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) K170808

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-05055343892626 Basic UDI-DI 05055343892626UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055343892626 UDI-DI Date18 Oct 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170808 Date13 Jul 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055343892626 registered 15 Oct 2026 Active
  • FDA 510(k) K170808 decided 13 Jul 2017 Active
  • FDA GUDID UDI-DI 05055343892626 listed 18 Oct 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170808
  2. Listed FDA GUDID 05055343892626
  3. Registered EUDAMED B-05055343892626

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  • Withdrawn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
DPI Drill Ø10.0mm EUDAMED
Unity Total Knee System GUDID
Generic name
Fluted surgical drill bit, reusable
Model / Ref / Catalog
CG000168, Unity Total Knee instrument set
Primary DI / UDI-DI
05055343892626
Basic UDI-DI
B-05055343892626
510(k) Number
FDA product code
JWH
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Fluted surgical drill bit, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3560
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 IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Fluted surgical drill bit, reusable

Cleared under the same submission (K170808)

and 8 more cleared under K170808

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)