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Apollo Knee COR.TS.0015

by Corin Ltd

Part of a family of 19 devices: see the family page

Ref COR.TS.0015Model ApolloKnee System

Apollo Knee COR.TS.0015 is a device classified as Class IIa in the EU and Class II in the US made by Corin Ltd, registered in EUDAMED on 22 Sep 2026 (Basic UDI-DI 50553438NVOBSNQ), cleared under FDA 510(k) K231172 on 26 Jul 2023 and listed in FDA GUDID since 17 Dec 2024 (UDI-DI 05056139246029), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231172

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number50553438NVOBSNQ Basic UDI-DI 05056139246029UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05056139246029 UDI-DI Date17 Dec 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK231172 Date26 Jul 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 50553438NVOBSNQ registered 22 Sep 2026 Active
  • FDA 510(k) K231172 decided 26 Jul 2023 Active
  • FDA GUDID UDI-DI 05056139246029 listed 17 Dec 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K231172
  2. Listed FDA GUDID 05056139246029
  3. Registered EUDAMED 50553438NVOBSNQ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Camera Assembly ST EUDAMED
Apollo Knee GUDID
Generic name
Robotic surgical telemanipulation system
Device name
ApolloKnee System intended to support the surgeon with total knee arthroplasty
Model / Ref / Catalog
COR.TS.0015, ApolloKnee System
Primary DI / UDI-DI
05056139246029
Basic UDI-DI
50553438NVOBSNQ
510(k) Number
FDA product code
OLO
EMDN code
Z12130480 Stereotactic orthopaedic surgery instruments - hardware accessories
GMDN term
Robotic surgical telemanipulation system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

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: Robotic surgical arm system

Cleared under the same submission (K231172)

and 8 more cleared under K231172

Similar devices in this category

Other devices filed under STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

  • Reusable
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)