TOWNLEY TOTAL ELBOW SYSTEM— 510(k) K955916
Substantially EquivalentBiologically Oriented Prostheses
FDA 510(k) clearance K955916 for TOWNLEY TOTAL ELBOW SYSTEM, Substantially Equivalent on 1996-08-08. Applicant: Biologically Oriented Prostheses.
Clearance details
- Applicant
- Biologically Oriented Prostheses
- Product code
- Code JDC
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Port Huron, MI, US
Adverse events under product code JDC
product code JDC- Injury
- 1,050
- Total
- 1,050
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.