Signature ONE Software Package 302.4018
Signature ONE Software Package 302.4018 is a Class II device made by Orthosoft Inc, cleared under FDA 510(k) K261510 on 4 Jun 2026 and listed in FDA GUDID since 10 Jul 2026 (UDI-DI 00889024707047), active as of 2 Nov 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 | Number00889024707047 | Date10 Jul 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK261510 | Date4 Jun 2026 | StatusActive |
Official records
- AccessGUDID record 00889024707047
- FDA 510(k) database K261510
Across registries
- FDA 510(k) K261510 decided 4 Jun 2026 Active
- FDA GUDID UDI-DI 00889024707047 listed 10 Jul 2026 Listed
Timeline
- Cleared FDA 510(k) K261510
- Listed FDA GUDID 00889024707047
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Signature ONE Software Package
- Generic name
- Orthopaedic surgical planning radiology software
- Model / Ref / Catalog
- 302.4018
- Primary DI / UDI-DI
- 00889024707047
- 510(k) Number
- FDA product code
- MBF, QHE, KWS, KWT, PHX, HSD
- GMDN term
- Orthopaedic surgical planning radiology software
- Device class
- Class II
- Regulation number
- 888.3670, 888.3660, 888.3650, 888.3690
- GUDID distribution status
- In Commercial Distribution