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510(k) K111596

TOTAL SHOULDER SYSTEM by Shoulder Innovations, LLC — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2011
Date Received
June 8, 2011
Clearance Type
Special
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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  • K192365 — Shoulder Innovations Total Shoulder System (November 29, 2019)
  • K173824 — Humeral Short Stem System (October 23, 2018)
  • K110905 — TOTAL SHOULDER SYSTEM (May 24, 2011)
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  • K230572 — AETOS Shoulder System (June 7, 2023)
  • K220847 — AETOS Shoulder System (January 3, 2023)
  • K222317 — Catalyst EA Convertible Stemmed Shoulder (November 10, 2022)