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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K080860
Device Name CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM
Applicant
Creaspine
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA J NOLTE
Correspondent
Creaspine
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA J NOLTE
Regulation Number888.3060
Classification Product Code
MQP  
Date Received03/27/2008
Decision Date 05/29/2008
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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