FDA 510(k) Application Details - K060009

Device Classification Name Cerclage, Fixation

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510(K) Number K060009
Device Name Cerclage, Fixation
Applicant ABBOTT SPINE, INC.
5301 RIATA PARK CT., BLDG. F
AUSTIN, TX 78727 US
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Contact LISA PETERSON
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Regulation Number 888.3010

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Classification Product Code JDQ
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Date Received 01/03/2006
Decision Date 03/06/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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