FDA 510(k) Application Details - K191367

Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar

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510(K) Number K191367
Device Name Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant ChoiceSpine LLC
400 Erin Drive
Knoxville, TN 37922 US
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Contact Kim Finch
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Regulation Number 888.3080

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Classification Product Code MAX
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Date Received 05/22/2019
Decision Date 07/05/2019
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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