FDA 510(k) Application Details - K240690

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K240690
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant Nexxt Spine
14425 Bergen Blvd, Suite B
Noblesville, IN 46060 US
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Contact Andy Elsbury
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 03/13/2024
Decision Date 03/22/2024
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

FDA Source Information for K240690


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