FDA 510(k) Application Details - K212594

Device Classification Name	Staple, Absorbable   More FDA Info for this Device
510(K) Number	K212594
Device Name	Staple, Absorbable
Applicant	OSSIO Ltd. 8 HaTochen St. Caesarea 3079861 IL Other 510(k) Applications for this Company
Contact	Taly Linder Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	MNU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2021
Decision Date	01/21/2022
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