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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 K090751
Device Name COMET ANTERIOR CERVICAL PLATE SYSTEM
Applicant
Apollo Spine, Inc.
75 Mill St.
Stoughton,  MA  02072
Applicant Contact ANN-MARIE FRANCIS
Correspondent
Apollo Spine, Inc.
75 Mill St.
Stoughton,  MA  02072
Correspondent Contact ANN-MARIE FRANCIS
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/20/2009
Decision Date 10/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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