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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 K040397
Device Name MODIFICATION TO 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 Received02/17/2004
Decision Date 05/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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