FDA 510(k) Application Details - K191084

Device Classification Name Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

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510(K) Number K191084
Device Name Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Applicant Optimotion Implants, LLC
5931 Brick Court, Suite 130
Winter Park, FL 32792 US
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Contact Dan Justin
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Regulation Number 888.3565

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Classification Product Code MBH
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Date Received 04/24/2019
Decision Date 04/07/2020
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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