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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 K936269
Device Name CASPAR TITANIUM ALLOY BONE SCREWS
Applicant
Aesculap, Inc.
1000 Gateway Blvd.
South San Francisco,  CA  94080
Applicant Contact VICTORIA MACKINNON
Correspondent
Aesculap, Inc.
1000 Gateway Blvd.
South San Francisco,  CA  94080
Correspondent Contact VICTORIA MACKINNON
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received12/30/1993
Decision Date 08/15/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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