Arvis ® In-21300
by Kico Knee Innovation Company Pty Limited
Arvis ® In-21300 is a Class II device made by Kico Knee Innovation Company Pty Limited, cleared under FDA 510(k) K240062 on 29 Apr 2024 and listed in FDA GUDID since 18 Mar 2025 (UDI-DI 00810180350983), 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 | GUDID listing | Number00810180350983 | Date18 Mar 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK240062 | Date29 Apr 2024 | StatusActive |
Official records
- AccessGUDID record 00810180350983
- FDA 510(k) database K240062
Across registries
- FDA 510(k) K240062 decided 29 Apr 2024 Active
- FDA GUDID UDI-DI 00810180350983 listed 18 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K240062
- Listed FDA GUDID 00810180350983
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Arvis ®
- Generic name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Model / reference
- IN-21300
- Primary DI / UDI-DI
- 00810180350983
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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