FDA 510(k) Application Details - K142867

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K142867
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant Reliance Medical Systems, LLC
545 West 500 South, Suite 100
Bountiful, UT 84010 US
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Contact Bret M. Berry
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 10/01/2014
Decision Date 04/29/2015
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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