Curiteva Navigation System C595-305-45
Curiteva Navigation System C595-305-45 is a Class II device made by Curiteva, LLC, cleared under FDA 510(k) K223200 on 6 Jan 2023 and listed in FDA GUDID since 2 Jul 2026 (UDI-DI B648C595305450), 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 | NumberB648C595305450 | Date2 Jul 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK223200 | Date6 Jan 2023 | StatusActive |
Official records
- FDA 510(k) database K223200
Across registries
- FDA 510(k) K223200 decided 6 Jan 2023 Active
- FDA GUDID UDI-DI B648C595305450 listed 2 Jul 2026 Listed
Timeline
- Cleared FDA 510(k) K223200
- Listed FDA GUDID B648C595305450
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Curiteva Navigation System
- Generic name
- Bone tap, reusable
- Model / reference
- C595-305-45
- Primary DI / UDI-DI
- B648C595305450
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Bone tap, reusable
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Outer Diameter — 4.5 Millimeter
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