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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 K080281
Device Name PATHWAY
Applicant
Custom Spine, Inc.
1140 Parsippany Blvd.
Suite 201
Parsippany,  NJ  07054
Applicant Contact SAAD ATTIYAH
Correspondent
Custom Spine, Inc.
1140 Parsippany Blvd.
Suite 201
Parsippany,  NJ  07054
Correspondent Contact SAAD ATTIYAH
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/04/2008
Decision Date 05/01/2008
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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