FDA 510(k) Application Details - K223112

Device Classification Name	Pin, Fixation, Threaded   More FDA Info for this Device
510(K) Number	K223112
Device Name	Pin, Fixation, Threaded
Applicant	Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 US Other 510(k) Applications for this Company
Contact	Allison Francis Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	JDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2022
Decision Date	12/08/2022
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