FDA 510(k) Application Details - K192494

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K192494
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant Precision Spine
2050 Executive Drive
Pearl, MS 39208 US
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Contact Michael C. Dawson
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 09/11/2019
Decision Date 10/29/2019
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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