FDA 510(k) Application Details - K241666

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K241666
Device Name	Plate, Fixation, Bone
Applicant	Smith & Nephew 1450 Brooks Road Memphis, TN 38116 US Other 510(k) Applications for this Company
Contact	Mandy Coe 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	06/10/2024
Decision Date	02/19/2025
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