FDA 510(k) Application Details - K221615

Device Classification Name	More FDA Info for this Device
510(K) Number	K221615
Device Name	Newclip Patient-matched instrumentation non sterile PSI
Applicant	Newclip Technics P.A. de la Lande Saint Martin - 45 rue des Garottieres Haute-Goulaine 44115 FR Other 510(k) Applications for this Company
Contact	Gaelle 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	06/03/2022
Decision Date	10/25/2023
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