FDA 510(k) Application Details - K210717

Device Classification Name	More FDA Info for this Device
510(K) Number	K210717
Device Name	Bone Screws dia. 5,0 mm
Applicant	LimaCorporate S.p.A. Via Nazionale 52 Villanova di San Daniele del Friuli 33038 IT Other 510(k) Applications for this Company
Contact	Antonia Trevisan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/10/2021
Decision Date	07/12/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review