FDA 510(k) Application Details - K202810

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component   More FDA Info for this Device
510(K) Number	K202810
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant	OrthoSpin Ltd 13 Hayezira St. Yokneam 2066720 IL Other 510(k) Applications for this Company
Contact	Oren Cohen Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	KTT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/2020
Decision Date	01/06/2021
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