spineEOS 3.0
by Eos Imaging
spineEOS 3.0 is a Class II device made by Eos Imaging, cleared under FDA 510(k) K232086 on 24 Oct 2023 and listed in FDA GUDID since 15 Feb 2024 (UDI-DI 03663999000184), active (FDA 510(k)), not in commercial distribution (GUDID) as of 12 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 | Number03663999000184 | Date15 Feb 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK232086 | Date24 Oct 2023 | StatusActive |
Official records
- AccessGUDID record 03663999000184
- FDA 510(k) database K232086
Across registries
- FDA 510(k) K232086 decided 24 Oct 2023 Active
- FDA GUDID UDI-DI 03663999000184 listed 15 Feb 2024 Listed
Timeline
- Cleared FDA 510(k) K232086
- Listed FDA GUDID 03663999000184
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- Withdrawn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
- 3.0
- Primary DI / UDI-DI
- 03663999000184
- 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
- Not in Commercial Distribution
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