FEI 3003179719
Spineology Inc.
7800 THIRD STREET N., Saint Paul, MN, US
MDR events135All time
Recalls1All time
Registered products15
Establishment typeManufactureManufacture Medical Device
Registered product codes
15 product codes
Recent MDR events
135 on file
- AFT ALLOGRAFT FILLER TUBEMay 19, 2026Malfunction2135156-2026-00002
- OPTIMESHJan 9, 2026Malfunction2135156-2026-00001
- OPTIMESHDec 22, 2025Injury2135156-2025-00012
- OPTIMESHNov 20, 2025Injury2135156-2025-00011
- OPTIMESHNov 12, 2025Injury2135156-2025-00010
- OPTIMESHOct 24, 2025Injury2135156-2025-00009
- AFT ALLOGRAFT FILLER TUBEOct 7, 2025Injury2135156-2025-00008
- OPTIMESHOct 1, 2025Injury2135156-2025-00006
- OPTIMESHOct 1, 2025Injury2135156-2025-00007
- ELITE EXPANDABLE INTERBODY FUSION DEVICESep 12, 2025Injury2135156-2025-00004
Compliance history
Matched by FEI 3003179719.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 17, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Apr 17, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.100(a)Apr 17, 2025
Lack of or inadequate procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.