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510(k) K241357

XT3 System by Biodynamik, Inc. — Product Code JDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2025
Date Received
May 14, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Threaded
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Biodynamik, Inc.

  • K260073 — XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm (February 10, 2026)

Other clearances for product code JDW

  • K260073 — XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm (February 10, 2026)
  • K250316 — Meduloc Intramedullary Fracture Fixation (IFF) System (October 29, 2025)
  • K223112 — MAVERICK Mini External Fixation System (December 8, 2022)
  • K213874 — MAVERICK External Fixation System (February 11, 2022)
  • K211508 — Steinmann Pins and Kirschner Wires (October 5, 2021)
  • K210784 — Extended HA Half Pins (April 2, 2021)
  • K200933 — Syntec Non-Sterile Steinmann Pins System (May 5, 2020)
  • K191803 — Orthopedic Fixation Pin (April 14, 2020)
  • K192768 — Temporary Fixation Pins (December 26, 2019)
  • K182171 — SMV Scientific K-Wire and Pins (October 25, 2018)