INSTRUMENTS, GENERAL HAND & SURGERY— 510(k) K760311
Substantially EquivalentDepuy, Inc.
FDA 510(k) clearance K760311 for INSTRUMENTS, GENERAL HAND & SURGERY, Substantially Equivalent on 1976-08-09. Applicant: Depuy, Inc..
Clearance details
- Applicant
- Depuy, Inc.
- Product code
- Code FSM
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code FSM
product code FSM- Malfunction
- 1,289
- Total
- 1,289
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.