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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 K012881
Device Name C3 ANTERIOR CERVICAL PLATE SYSTEM
Applicant
Spine Vision, Inc.
Box 39 367 Pleasant Valley Rd.
Good Hope,  GA  30641
Applicant Contact DAVID W MULLIS, JR
Correspondent
Spine Vision, Inc.
Box 39 367 Pleasant Valley Rd.
Good Hope,  GA  30641
Correspondent Contact DAVID W MULLIS, JR
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/28/2001
Decision Date 11/26/2001
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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