FDA 510(k) Application Details - K173787

Device Classification Name Spinal Vertebral Body Replacement Device

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510(K) Number K173787
Device Name Spinal Vertebral Body Replacement Device
Applicant Medos International SARL
Chemin-Blanc 38
Le Locle 2400 CH
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Contact Sheree Geller
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Regulation Number 888.3060

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Classification Product Code MQP
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Date Received 12/14/2017
Decision Date 06/11/2018
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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