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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 K010911
Device Name MACROPORE OS SPINAL SYSTEM
Applicant
Macropore Biosurgery, Inc.
6740 Top Gun St.
San Diego,  CA  92121
Applicant Contact KENNETH K KLEINHENZ
Correspondent
Macropore Biosurgery, Inc.
6740 Top Gun St.
San Diego,  CA  92121
Correspondent Contact KENNETH K KLEINHENZ
Regulation Number888.3060
Classification Product Code
KWQ  
Subsequent Product Code
HRS  
Date Received03/26/2001
Decision Date 07/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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