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510(k) K250316

Meduloc Intramedullary Fracture Fixation (IFF) System by Meduloc, LLC — Product Code JDW

K250316 is an FDA 510(k) premarket notification submitted by Meduloc, LLC for the device "Meduloc Intramedullary Fracture Fixation (IFF) System". The FDA issued a decision of Substantially Equivalent on October 29, 2025. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2025
Date Received
February 4, 2025
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 for product code JDW

  • K260073 — XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm (February 10, 2026)
  • K241357 — XT3 System (January 22, 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)

FDA data resources