FEI 3008747271
Toby Orthopaedics
6355 SW 8th Street, Suite 101, Miami, FL, US
MDR events7All time
Recalls1All time
Registered products11
Establishment typeManufactureManufacture Medical Device
Registered product codes
11 product codes
Recent MDR events
7 on file
- PANTERA PROXIMAL HUMERUS FRACTURE FIXATION PLATENov 3, 2020Malfunction3008747271-2020-00001
- PANTERA PROXIMAL HUMERUS FRACTURE FIXATION PLATE, LEFT 73MMDec 28, 2015MalfunctionMW5058794
- PANTERA PROXIMAL HUMERUS FRACTURE FIXATION PLATE, LEFT 73MMDec 28, 2015MalfunctionMW5058795
- PANTERA PLATE SYSTEM, INSTRUMENTATIONOct 18, 2013Malfunction3008747271-2013-00003
- PANTERA PROXIMAL HUMERUS FRACTURE FIXATION PLATEJun 25, 2013Malfunction3008747271-2013-00001
- PANTERA PROXIMAL HUMERUS FRACTURE FIXATION PLAJun 25, 2013Malfunction3008747271-2013-00002
- PANTERA PROXIMAL HUMERUS FRACTURE FIXATION PLATE 83 MMJul 6, 2012InjuryMW5026109
Compliance history
Matched by FEI 3008747271.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jul 15, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jul 15, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.20(c)Jul 15, 2025
Management review - defined interval, sufficient frequency
- 21 CFR 820.22Jul 15, 2025
Quality Audits - defined intervals
- 21 CFR 820.30(g)Jul 15, 2025
Design validation - documentation
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.