FEI 3012491394
Summit Orthopedic Technologies Inc.
2975 Horseshoe Drive South, Naples, FL, US
MDR events0All time
Recalls0All time
Registered products11
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
11 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 3012491394.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Feb 15, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Feb 15, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.72(a)Feb 15, 2024
Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.90(a)Feb 15, 2024
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Feb 15, 2024
Lack of or inadequate procedures
- 21 CFR 820.198(b)Feb 15, 2024
Review and evaluation for investigation
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.