FEI 3006215390
Unified Spine, Llc
6295 Maxtown Road, Westerville, OH, US
MDR events0All time
Recalls0All time
Registered products16
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
16 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3006215390.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Mar 1, 2024
Compliance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(i)Mar 1, 2024
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.40Mar 1, 2024
Procedures not adequately established or maintained
- 21 CFR 820.50Mar 1, 2024
Purchasing controls, 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.