SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL— 510(k) K123745
Substantially EquivalentBiomecanica Industria E Comerico DE Productos Orto
FDA 510(k) clearance K123745 for SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL, Substantially Equivalent on 2013-03-25. Applicant: Biomecanica Industria E Comerico DE Productos Orto.
Clearance details
- Applicant
- Biomecanica Industria E Comerico DE Productos Orto
- Product code
- Code HSB
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Aventura, FL, US
Adverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.