FDA 510(k) Application Details - K210754

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K210754
Device Name	Screw, Fixation, Bone
Applicant	OsteoCentric Technologies 75 West 300 North, Suite #150 Logan, UT 84321 US Other 510(k) Applications for this Company
Contact	Todd Evans Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2021
Decision Date	04/14/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review