ACTIFY 3D Total Knee System, ACTIFY Total Knee System— 510(k) K240669
Substantially EquivalentGlobus Medical, Inc.
FDA 510(k) clearance K240669 for ACTIFY 3D Total Knee System, ACTIFY Total Knee System, Substantially Equivalent on 2024-06-20. Applicant: Globus Medical, Inc..
Clearance details
- Applicant
- Globus Medical, Inc.
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Audubon, PA, 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.