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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 K031214
Device Name CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
Applicant
ENCORE MEDICAL, L.P.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Applicant Contact DEBBIE DE LOS SANTOS
Correspondent
ENCORE MEDICAL, L.P.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Correspondent Contact DEBBIE DE LOS SANTOS
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/17/2003
Decision Date 09/23/2003
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
Recalls CDRH Recalls
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