FDA 510(k) Application Details - K203421

Device Classification Name	More FDA Info for this Device
510(K) Number	K203421
Device Name	Triathlon AS-1
Applicant	Conformis Inc. 600 Technology Park Drive, 4th Floor Billerica, MA 01821 US Other 510(k) Applications for this Company
Contact	Mary Kruitwagen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OOG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2020
Decision Date	04/19/2021
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