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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K040130
Device Name ANTERIOR LUMBAR BUTTRESS SYSTEM
Applicant
Seaspine
727 Park Blvd.
San Diego,  CA  92101
Applicant Contact DIANA SMITH
Correspondent
Seaspine
727 Park Blvd.
San Diego,  CA  92101
Correspondent Contact DIANA SMITH
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received01/21/2004
Decision Date 03/26/2004
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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