Medacta Anatomic Shoulder Prosthesis— 510(k) K170910
Substantially EquivalentMedacta International S.A.
FDA 510(k) clearance K170910 for Medacta Anatomic Shoulder Prosthesis, Substantially Equivalent on 2017-08-16. Applicant: Medacta International S.A..
Clearance details
- Applicant
- Medacta International S.A.
- Product code
- Code KWS
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castel San Pietro (Ch), CH
Adverse events under product code KWS
product code KWS- Death
- 6
- Injury
- 9,652
- Malfunction
- 1,385
- Other
- 1
- Total
- 11,044
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.