FDA 510(k) Application Details - K241219

Device Classification Name	More FDA Info for this Device
510(K) Number	K241219
Device Name	FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)
Applicant	ZuriMed Technologies AG Lengghalde 5 Zurich 8008 CH Other 510(k) Applications for this Company
Contact	Elias Bachman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2024
Decision Date	12/11/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review