Unity Total Knee System— 510(k) K170808
Substantially EquivalentCorin U.S.A. Limited
FDA 510(k) clearance K170808 for Unity Total Knee System, Substantially Equivalent on 2017-07-13. Applicant: Corin U.S.A. Limited. Device class: 2.
Clearance details
- Applicant
- Corin U.S.A. Limited
- Product code
- Code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tampa, FL, US
Recent devices under product code JWH
view allMore clearances from Corin U.S.A. Limited
view allAdverse 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.