360CAS Kic-Dnd-0002
by Kico Knee Innovation Company Pty Limited
360CAS Kic-Dnd-0002 is a Class II device made by Kico Knee Innovation Company Pty Limited, cleared under FDA 510(k) K213380 on 11 Jan 2022 and listed in FDA GUDID since 16 Aug 2022 (UDI-DI B432360CAS00020), 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 | GUDID listing | NumberB432360CAS00020 | Date16 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213380 | Date11 Jan 2022 | StatusActive |
Official records
- FDA 510(k) database K213380
Across registries
- FDA 510(k) K213380 decided 11 Jan 2022 Active
- FDA GUDID UDI-DI B432360CAS00020 listed 16 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K213380
- Listed FDA GUDID B432360CAS00020
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- Withdrawn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-0002
- Primary DI / UDI-DI
- B432360CAS00020
- 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
- Sterilisation method
- Hydrogen Peroxide
- MRI safety
- MR Unsafe
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