FDA 510(k) Application Details - K202887

Device Classification Name

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510(K) Number K202887
Device Name IlluminOss Bone Stabilization System
Applicant IlluminOss Medical, Inc.
993 Waterman Avenue
East Providence, RI 02914 US
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Contact Robert Rabiner
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Regulation Number

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Classification Product Code QAD
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Date Received 09/28/2020
Decision Date 10/27/2020
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 K202887


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