M.U.S.T. MINI Posterior Cervical Screws System— 510(k) K203149

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K203149 for M.U.S.T. MINI Posterior Cervical Screws System, Substantially Equivalent on 2020-11-16. Applicant: Medacta International S.A..

Clearance details

Applicant
Medacta International S.A.
Product code
Code NKG
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Castel San Pietro (Ch), CH
Download summary PDFView on FDA.gov ↗

Adverse events under product code NKG

product code NKG
Death
15
Injury
1,090
Malfunction
529
Total
1,634

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.