FDA 510(k) Application Details - K222820

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K222820
Device Name	Screw, Fixation, Bone
Applicant	BRM Extremities Via Papa Giovanni XXIII, 9 Civate 23862 IT Other 510(k) Applications for this Company
Contact	Lisa Fazzini 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	09/19/2022
Decision Date	12/16/2022
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