FDA 510(k) Application Details - K251310

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K251310
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	OTS Medical Ltd. 94 Yigal Alon St., Floor 31 Tel Aviv 6789139 IL Other 510(k) Applications for this Company
Contact	Dekel Assaf Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	MBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2025
Decision Date	07/22/2025
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