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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K193106
Device Name SpineFrontier Lumbar Interbody Fusion Device System
Applicant
Spinefrontier, Inc.
350 Main St.
Malden,  MA  02148
Applicant Contact Vito Lore
Correspondent
Spinefrontier, Inc.
350 Main St.
2nd Floor
Malden,  MA  02148
Correspondent Contact Omkar Joglekar
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/08/2019
Decision Date 06/19/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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