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510(k) K240090

Argo Knotless GENESYS Anchor by Conmed Corporation — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2024
Date Received
January 12, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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Other clearances for product code MAI

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  • K251309 — OSSIOfiber® Suture Anchor (May 27, 2025)
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  • K243760 — OSSIOfiber® Suture Anchor 2.5-3.5 mm (April 3, 2025)
  • K250526 — Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor (March 14, 2025)
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