FDA 510(k) Application Details - K183506

Device Classification Name	Fastener, Fixation, Biodegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K183506
Device Name	Fastener, Fixation, Biodegradable, Soft Tissue
Applicant	Medos International SARL Chemin-Blanc 38, Case Postale Le Locle CH 2400 CH Other 510(k) Applications for this Company
Contact	Tatyana Korsunsky Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	MAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2018
Decision Date	02/14/2019
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