spineEOS 1.x
spineEOS 1.x is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Onefit Medical, cleared under FDA 510(k) K160407 on 8 Apr 2016 and listed in FDA GUDID since 27 Jun 2017 (UDI-DI 03700757200858), 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 | Number03700757200858 | Date27 Jun 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160407 | Date8 Apr 2016 | StatusActive |
Official records
- AccessGUDID record 03700757200858
- FDA 510(k) database K160407
Across registries
- FDA 510(k) K160407 decided 8 Apr 2016 Active
- FDA GUDID UDI-DI 03700757200858 listed 27 Jun 2017 Listed
Timeline
- Cleared FDA 510(k) K160407
- Listed FDA GUDID 03700757200858
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- spineEOS
- Generic name
- Orthopaedic/craniofacial implantation planning software
- Model / reference
- 1.x
- Primary DI / UDI-DI
- 03700757200858
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Orthopaedic/craniofacial implantation planning software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Orthopaedic/craniofacial implantation planning software.