FDA Device Entity Profile: Medacta International SA

Known Identifiers & Locations

FEI Numbers 3005180920, 3007319107, 3008110533

Owner Operator Numbers 10024526

Locations Covered Castel San Pietro Ticino, CH; Rancate Ticino, CH; Sarasota, FL, US

Registered Establishments (3)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3005180920	MEDACTA INTERNATIONAL SA	Castel San Pietro Ticino, CH	Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device	View Details
3007319107	PARCUS MEDICAL , L.L.C.	Sarasota, FL, US	Manufacture Medical Device	View Details
3008110533	MEDACTA INTERNATIONAL SA	Rancate Ticino, CH	Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K211664	GMK Sphere Revision	2021-07-29	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

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