FDA 510(k) Application Details - K071377

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K071377
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant BIOMET SPINE
100 INTERPACE PARKWAY
PARSIPPANY, NJ 07054 US
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Contact DEBRA BING
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 05/17/2007
Decision Date 08/06/2007
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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