FDA 510(k) Application Details - K000009

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K000009
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK, CT 06856 US
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Contact LUIS NESPRIDO
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 01/03/2000
Decision Date 03/10/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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