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510(k) K232905

Medline UNITE® REFLEX® Nitinol Staple Kit by Medline Industries, LP — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2023
Date Received
September 19, 2023
Clearance Type
Special
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)
  • K243742 — Arthrex DynaNite Nitinol Staples (January 31, 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)
  • K232324 — StealthFix Intraosseous Fixation System (August 30, 2023)
  • K232387 — Treace Medical Concepts (TMC) Compression Implant System (August 28, 2023)