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510(k) K213816

MPO Hip Instruments by Microport Orthopedics, Inc. — Product Code JDI

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, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

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Other clearances for product code JDI

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  • K240418 — Stryker Orthopaedics Hip Systems Labeling Update (April 12, 2024)
  • K233261 — Global Modular Replacement System (December 8, 2023)
  • K222056 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (January 26, 2023)
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  • K213701 — Exeter® X3® RimFit® Cup (February 1, 2022)
  • K210842 — VerSys Cemented Revision/Calcar (December 10, 2021)
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