FDA 510(k) Application Details - K221938

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K221938
Device Name	Plate, Fixation, Bone
Applicant	KLS Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville, FL 32246 US Other 510(k) Applications for this Company
Contact	Melissa Bachorski 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	07/01/2022
Decision Date	03/28/2023
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