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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 K072120
Device Name PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE
Applicant
Innovative Spinal Technologies, Inc.
111 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact GINA YEH
Correspondent
Innovative Spinal Technologies, Inc.
111 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact GINA YEH
Regulation Number888.3080
Classification Product Code
MAX  
Date Received08/01/2007
Decision Date 10/11/2007
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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