FDA 510(k) Application Details - K172115

Device Classification Name Orthopedic Stereotaxic Instrument

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510(K) Number K172115
Device Name Orthopedic Stereotaxic Instrument
Applicant Orthofix Inc.
3451 Plano Parkway
Lewisville, TX 75056 US
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Contact Jacki Koch
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Regulation Number 882.4560

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Classification Product Code OLO
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Date Received 07/13/2017
Decision Date 03/08/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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