FDA 510(k) Application Details - K234059

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K234059
Device Name	Plate, 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 Gault Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2023
Decision Date	06/26/2024
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