FDA 510(k) Application Details - K120390

Device Classification Name Screw, Fixation, Bone

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510(K) Number K120390
Device Name Screw, Fixation, Bone
Applicant SOLANA SURGICAL LLC
6363 POPLAR AVE
SUITE 434
MEMPHIS, TN 38119 US
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Contact LOUISE ROCHT
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 02/07/2012
Decision Date 04/10/2012
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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