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Cori ROB10100

by Smith & Nephew, Inc.

Cori ROB10100 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K221224 on 19 Aug 2022 and listed in FDA GUDID since 14 Dec 2022 (UDI-DI 00885556809600), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K221224

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885556809600 UDI-DI Date14 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK221224 Date19 Aug 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K221224 decided 19 Aug 2022 Active
  • FDA GUDID UDI-DI 00885556809600 listed 14 Dec 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K221224
  2. Listed FDA GUDID 00885556809600

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cori
Generic name
Orthopaedic knee-balance analyser, electrically-powered
Model / Ref / Catalog
ROB10100
Primary DI / UDI-DI
00885556809600
510(k) Number
FDA product code
OLO
GMDN term
Orthopaedic knee-balance analyser, electrically-powered
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic knee-balance analyser, electrically-powered

Cleared under the same submission (K221224)

Similar devices

Other devices filed under FDA product code OLO (Orthopedic stereotaxic instrument).

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (12, all answered No)