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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 K103838
Device Name FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
Applicant
Precision Surgery , Ltd.
8202 Sherman Rd.
Chesterland,  OH  44026
Applicant Contact KAREN E WARDEN, PHD.
Correspondent
Precision Surgery , Ltd.
8202 Sherman Rd.
Chesterland,  OH  44026
Correspondent Contact KAREN E WARDEN, PHD.
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received12/30/2010
Decision Date 02/15/2011
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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