FDA 510(k) Application Details - K102689

Device Classification Name Plate, Fixation, Bone

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510(K) Number K102689
Device Name Plate, Fixation, Bone
Applicant CONVENTUS ORTHOPAEDICS
1331 H STREET NW
12TH FLOOR
WASHINGTON, DC 20005 US
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Contact HOLLACE S RHODES
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 09/17/2010
Decision Date 01/17/2013
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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