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510(k) K243742

Arthrex DynaNite Nitinol Staples by Arthrex, Inc. — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2025
Date Received
December 4, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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Other clearances for product code JDR

  • K250712 — Linkt Compression Staple System (May 14, 2025)
  • K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System (April 11, 2025)
  • K243658 — TMC Compression Implant System (December 26, 2024)
  • K242415 — TMC Compression Implant System (September 6, 2024)
  • K240212 — COGNiTiON™ Staple System (February 23, 2024)
  • K232990 — A’TOMIC™ Nitinol Fixation System (January 12, 2024)
  • K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (December 4, 2023)
  • K232905 — Medline UNITE® REFLEX® Nitinol Staple Kit (October 19, 2023)
  • K232324 — StealthFix Intraosseous Fixation System (August 30, 2023)
  • K232387 — Treace Medical Concepts (TMC) Compression Implant System (August 28, 2023)