360CAS Knee
by Kico Knee Innovation Company Pty Ltd
510(k) K242009
360CAS Knee is a Class II device made by Kico Knee Innovation Company Pty Ltd, cleared under FDA 510(k) K242009 on 8 Aug 2024, active as of 22 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 | NumberK242009 | Date8 Aug 2024 | StatusActive |
Official records
- FDA 510(k) database K242009
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- FDA applicant
- Kico Knee Innovation Company Pty, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K242009
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| 360CAS KIC-DND-0235 | KIC-DND-0235 | B432360CAS02350 | — | On the market |
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