GMK Spherika Femurs and Fixed Tibial Trays Plus— 510(k) K211004
Substantially EquivalentMedacta International S.A.
FDA 510(k) clearance K211004 for GMK Spherika Femurs and Fixed Tibial Trays Plus, Substantially Equivalent on 2021-05-13. Applicant: Medacta International S.A.. Device class: 2.
Clearance details
- Applicant
- Medacta International S.A.
- 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
- Castel San Pietro (Ch), CH
Recent devices under product code JWH
view allMore clearances from Medacta International S.A.
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.