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510(k) K142413

TITAN Modular Total Shoulder System by Ascension Orthopedics — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2014
Date Received
August 28, 2014
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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  • K121826 — INTEGRA PROXIMAL HUMERAL PLATE SYSTEM (February 13, 2013)
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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)