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510(k) K162903

Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies by Exactech, Inc. — Product Code KWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2017
Date Received
October 17, 2016
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

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Other clearances for product code KWT

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  • K241944 — AGILON® XO Shoulder Replacement System (March 10, 2025)
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  • 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)