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510(k) K190521

Aequalis Ascend Flex Shoulder System by Tornier S.A.S. — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2019
Date Received
March 4, 2019
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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  • K222317 — Catalyst EA Convertible Stemmed Shoulder (November 10, 2022)