DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORDINATE ULTRA KNEE REVISION SYSTEM— 510(k) K982585
Substantially Equivalent for Some IndicationsDePuy Orthopaedics, Inc.
FDA 510(k) clearance K982585 for DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORDINATE ULTRA KNEE REVISION SYSTEM, Substantially Equivalent for Some Indications on 1998-10-05. Applicant: DePuy Orthopaedics, Inc..
Clearance details
- Applicant
- DePuy Orthopaedics, Inc.
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Adverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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.