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510(k) K230724

arcad® 2.0 Duo & Quadro osteosynthesis compressive staples by Novastep — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2023
Date Received
March 16, 2023
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

Other clearances by Novastep

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  • K151277 — Airlock® osteosynthesis plate system (August 13, 2015)
  • K143523 — Airlock osteosynthesis plate system (April 6, 2015)
  • K143049 — LYNC intramedullary implant (February 19, 2015)
  • K143229 — Nexis osteosynthesis compressive screws (February 6, 2015)
  • K143146 — Nexis osteosynthesis snap-off screws (February 6, 2015)

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  • 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)
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  • K232324 — StealthFix Intraosseous Fixation System (August 30, 2023)
  • K232387 — Treace Medical Concepts (TMC) Compression Implant System (August 28, 2023)