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510(k) K241716

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2024
Date Received
June 14, 2024
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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Other clearances for product code JDI

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  • K222056 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (January 26, 2023)
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