FDA 510(k) Application Details - K063070

Device Classification Name Screw, Fixation, Bone

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510(K) Number K063070
Device Name Screw, Fixation, Bone
Applicant CAYENNE MEDICAL, INC.
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO, CA 92130 US
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Contact Floyd Larson
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 10/06/2006
Decision Date 12/14/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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