TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION— 510(k) K071090
Substantially EquivalentZimmer Trabecular Metal Technology
FDA 510(k) clearance K071090 for TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION, Substantially Equivalent on 2007-06-29. Applicant: Zimmer Trabecular Metal Technology.
Clearance details
- Applicant
- Zimmer Trabecular Metal Technology
- Product code
- Code KWS
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Parsippany, NJ, US
Adverse events under product code KWS
product code KWS- Death
- 6
- Injury
- 9,652
- Malfunction
- 1,385
- Other
- 1
- Total
- 11,044
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.