ENCORE CLP OFFSET TOTAL HIP SYSTEM— 510(k) K052320
Substantially EquivalentEncore Medical Corporation
FDA 510(k) clearance K052320 for ENCORE CLP OFFSET TOTAL HIP SYSTEM, Substantially Equivalent on 2005-12-30. Applicant: Encore Medical Corporation.
Clearance details
- Applicant
- Encore Medical Corporation
- Product code
- Code KWA
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hunt Valley, MD, US
Adverse events under product code KWA
product code KWA- Death
- 38
- Injury
- 10,439
- Malfunction
- 1,862
- Total
- 12,339
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.