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360CAS 2.2.0

by Kico Knee Innovation Company Pty Limited

360CAS 2.2.0 is a Class II device made by Kico Knee Innovation Company Pty Limited, cleared under FDA 510(k) K223927 on 27 Jan 2023 and listed in FDA GUDID since 26 Sep 2024 (UDI-DI B432360CAS2200), 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) K223927

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 NumberB432360CAS2200 UDI-DI Date26 Sep 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK223927 Date27 Jan 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223927 decided 27 Jan 2023 Active
  • FDA GUDID UDI-DI B432360CAS2200 listed 26 Sep 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K223927
  2. Listed FDA GUDID B432360CAS2200

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
360CAS
Generic name
Robotic surgical navigation system application software
Model / reference
2.2.0
Primary DI / UDI-DI
B432360CAS2200
510(k) Number
FDA product code
OLO
GMDN term
Robotic surgical navigation system application software
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

Other devices from Kico Knee Innovation Company Pty Limited

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Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)