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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 K111726
Device Name PATHWAY AVID
Applicant
Custom Spine, Inc.
1140 Parsippany Blvd.
Suite 201
Parsippany,  NJ  07054
Applicant Contact DAVID DRUMFIELD
Correspondent
Custom Spine, Inc.
1140 Parsippany Blvd.
Suite 201
Parsippany,  NJ  07054
Correspondent Contact DAVID DRUMFIELD
Regulation Number888.3080
Classification Product Code
MAX  
Date Received06/20/2011
Decision Date 02/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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