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510(k) K201519

PROFEMUR® GLADIATOR® Cemented Classic Stem by Microport Orthopedics, Inc. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2020
Date Received
June 8, 2020
Clearance Type
Traditional
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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  • K230563 — EVOLUTION® Hinge Knee System (September 27, 2023)
  • K213817 — MPO Knee Instruments; MPO PROPHECY Knee Instruments (January 5, 2022)
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Other clearances for product code JDI

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  • K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectr (October 21, 2024)
  • K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (August 2, 2024)
  • 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)
  • K220216 — C-Stem AMT LE Prosthesis (July 22, 2022)
  • K213701 — Exeter® X3® RimFit® Cup (February 1, 2022)
  • K213816 — MPO Hip Instruments (January 5, 2022)
  • K210842 — VerSys Cemented Revision/Calcar (December 10, 2021)