360CAS Kic-Dnd-0010
by Kico Knee Innovation Company Pty Limited
360CAS Kic-Dnd-0010 is a Class II device made by Kico Knee Innovation Company Pty Limited, cleared under FDA 510(k) K223927 on 27 Jan 2023 (1 earlier submission) and listed in FDA GUDID since 16 Aug 2022 (UDI-DI B432360CAS00100), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223927 | Date27 Jan 2023 | StatusActive |
| United States | GUDID listing | NumberB432360CAS00100 | Date16 Aug 2022 | StatusListed |
Official records
- FDA 510(k) database K223927
- FDA 510(k) database K213380
Across registries
- FDA 510(k) K223927 decided 27 Jan 2023 Active
- FDA GUDID UDI-DI B432360CAS00100 listed 16 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K213380
- Listed FDA GUDID B432360CAS00100
- Cleared FDA 510(k) K223927
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- 360CAS
- Generic name
- Robotic surgical navigation system application software
- Model / reference
- KIC-DND-0010
- Primary DI / UDI-DI
- B432360CAS00100
- 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
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Unsafe
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