The Progressive Orthopaedic Company Total Knee System II— 510(k) K183344
Substantially EquivalentThe Progressive Orthopaedic Company, LLC
FDA 510(k) clearance K183344 for The Progressive Orthopaedic Company Total Knee System II, Substantially Equivalent on 2019-03-18. Applicant: The Progressive Orthopaedic Company, LLC.
Clearance details
- Applicant
- The Progressive Orthopaedic Company, LLC
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palm Beach Gardens, FL, 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.