TOTAL HIP, NEW ENGLAND BAPTIST— 510(k) K780329
Substantially EquivalentDepuy, Inc.
FDA 510(k) clearance K780329 for TOTAL HIP, NEW ENGLAND BAPTIST, Substantially Equivalent on 1978-03-17. Applicant: Depuy, Inc..
Clearance details
- Applicant
- Depuy, Inc.
- Product code
- Code JDG
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code JDG
product code JDG- Injury
- 804
- Malfunction
- 3,242
- Total
- 4,046
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.