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510(k) K213817

MPO Knee Instruments; MPO PROPHECY Knee Instruments by Microport Orthopedics, Inc. — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2022
Date Received
December 7, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3565
Review Panel
OR
Submission Type

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  • K230563 — EVOLUTION® Hinge Knee System (September 27, 2023)
  • K213816 — MPO Hip Instruments (January 5, 2022)
  • K200011 — E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS (October 1, 2021)

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