FDA 510(k) Application Details - K221645

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K221645
Device Name	Screw, Fixation, Bone
Applicant	Wright Medical Technology 1023 Cherry Road Memphis, TN 38117 US Other 510(k) Applications for this Company
Contact	Anna Bushart 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	06/06/2022
Decision Date	02/17/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review