FDA 510(k) Application Details - K211076

Device Classification Name	More FDA Info for this Device
510(K) Number	K211076
Device Name	Patient Specific Marking Guides
Applicant	Additive Orthopaedics, LLC 44 Riverdale Ave Monmouth Beach, NJ 07750 US Other 510(k) Applications for this Company
Contact	Greg Kowalczyk 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	04/12/2021
Decision Date	06/28/2022
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