FDA 510(k) Application Details - K092128

Device Classification Name Orthosis, Spinal Pedicle Fixation

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510(K) Number K092128
Device Name Orthosis, Spinal Pedicle Fixation
Applicant SPINAL USA
2050 EXECUTIVE DR.
PEARL, MS 39208 US
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Contact JEFFREY JOHNSON
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Regulation Number 888.3070

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Classification Product Code MNI
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Date Received 07/15/2009
Decision Date 09/14/2009
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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