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510(k) K241609

Tornier Humeral Reconstruction System (Tornier HRS) by Stryker Corporation (Tornier, Inc.) — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2024
Date Received
June 5, 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

Other clearances by Stryker Corporation (Tornier, Inc.)

  • K241878 — Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral Sys (December 6, 2024)

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  • K241878 — Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral Sys (December 6, 2024)
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  • K220847 — AETOS Shoulder System (January 3, 2023)
  • K222317 — Catalyst EA Convertible Stemmed Shoulder (November 10, 2022)
  • K213387 — AltiVate® Anatomic Shoulder AG e+™ with Markers (July 7, 2022)