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510(k) K241292

MyShoulder Planner (5.3SSWPL) by Medacta International S.A. — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2025
Date Received
May 8, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

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  • K220847 — AETOS Shoulder System (January 3, 2023)
  • K222317 — Catalyst EA Convertible Stemmed Shoulder (November 10, 2022)
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