FDA 510(k) Application Details - K230945

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K230945
Device Name	Screw, Fixation, Bone
Applicant	Forma Medical, Inc. 3401 Hartzdale Drive, Suite 103B, Unit #611 Camp Hill, PA 17011 US Other 510(k) Applications for this Company
Contact	James A. Gault 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	04/04/2023
Decision Date	07/18/2023
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