FDA 510(k) Application Details - K243912

Device Classification Name	More FDA Info for this Device
510(K) Number	K243912
Device Name	Newclip Patient-matched instrumentation non sterile PSI
Applicant	NewClip Technics PA de la Lande Saint Martin 45 rue des GarottiΦres Haute Goulaine 44115 FR Other 510(k) Applications for this Company
Contact	Gaδlle Gourbiere Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2024
Decision Date	02/13/2025
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