FDA 510(k) Application Details - K210837

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K210837
Device Name	Plate, Fixation, Bone
Applicant	Smith & Nephew, Inc. 1450 E Brooks Rd Memphis, TN 38116 US Other 510(k) Applications for this Company
Contact	Thomas Fearnley 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	03/22/2021
Decision Date	06/29/2021
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