FDA 510(k) Application Details - K142744

Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical

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510(K) Number K142744
Device Name Intervertebral Fusion Device With Bone Graft, Cervical
Applicant Medacta International
Strada Regina
Castel San Pietro ch 6874 CH
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Contact Adam Gross
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Regulation Number 888.3080

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Classification Product Code ODP
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Date Received 09/24/2014
Decision Date 05/07/2015
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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