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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 K170512
Device Name Altus Spine Titanium Interbody Fusion System
Applicant
Altus Partners, LLC
1340 Enterprise Dr.
West Chester,  PA  19380
Applicant Contact Claudia Hill
Correspondent
Altus Partners, LLC
1340 Enterprise Dr.
West Chester,  PA  19380
Correspondent Contact Claudia Hill
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/21/2017
Decision Date 03/10/2017
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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