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510(k) K191811

Catalyst OrthoScience CSR Shoulder System by Catalyst Orthoscience, Inc. — Product Code KWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2019
Date Received
July 5, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3650
Review Panel
OR
Submission Type

Other clearances by Catalyst Orthoscience, Inc.

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  • K232583 — Catalyst R1 Reverse Shoulder System (September 20, 2023)
  • K223655 — Catalyst R1 Reverse Shoulder System (May 9, 2023)
  • K222317 — Catalyst EA Convertible Stemmed Shoulder (November 10, 2022)
  • K213349 — Catalyst R1 Reverse Shoulder System (June 23, 2022)
  • K211991 — Catalyst R1 Reverse Shoulder System (July 28, 2021)
  • K202611 — Catalyst OrthoScience R1 Reverse Shoulder System (February 12, 2021)
  • K182500 — Catalyst CSR Press-Fit Humeral Components (January 11, 2019)
  • K181287 — Catalyst CSR Shoulder System (July 12, 2018)

Other clearances for product code KWT

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  • K241944 — AGILON® XO Shoulder Replacement System (March 10, 2025)
  • K241817 — InSet Total Shoulder System (February 11, 2025)
  • K231657 — AGILON® XO Shoulder Replacement System (February 16, 2024)
  • K223631 — Comprehensive Segmental Revision System(SRS) (July 12, 2023)
  • K222482 — AGILON XO Shoulder System (September 28, 2022)
  • K210899 — LINK Embrace Shoulder System- Anatomical Configuration (June 21, 2021)
  • K191698 — TiN Coated Humeral Head (July 16, 2020)
  • K192365 — Shoulder Innovations Total Shoulder System (November 29, 2019)