FDA 510(k) Application Details - K213659

Device Classification Name	More FDA Info for this Device
510(K) Number	K213659
Device Name	LigaPASSÖ 2.0 Ligament Augmentation System
Applicant	Medicrea International S. A. 5389 Route De Strasbourg - Vancia Rillieux-La-Pape 69140 FR Other 510(k) Applications for this Company
Contact	Teal Bjoraker Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2021
Decision Date	05/24/2022
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