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510(k) K212356

Exactech® Equinoxe® Laser Cage Glenoid by Exactech, Inc. — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2022
Date Received
July 29, 2021
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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  • K223933 — Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws (September 25, 2023)
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Other clearances for product code KWS

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  • K241609 — Tornier Humeral Reconstruction System (Tornier HRS) (September 10, 2024)
  • K230513 — Arthrex Univers Apex OptiFit Humeral Stem (September 26, 2023)
  • K222592 — AltiVate® Anatomic Shoulder AG e+™ with Markers (June 23, 2023)
  • K230572 — AETOS Shoulder System (June 7, 2023)
  • K220847 — AETOS Shoulder System (January 3, 2023)
  • K222317 — Catalyst EA Convertible Stemmed Shoulder (November 10, 2022)