FDA 510(k) Application Details - K233302

Device Classification Name	Staple, Absorbable   More FDA Info for this Device
510(K) Number	K233302
Device Name	Staple, Absorbable
Applicant	Ossio Ltd. 8 HaTochen St. Caesarea 3079861 IL Other 510(k) Applications for this Company
Contact	Taly Lindner 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	09/29/2023
Decision Date	11/16/2023
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