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510(k) K223112

MAVERICK Mini External Fixation System by Smith & Nephew, Inc. — Product Code JDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2022
Date Received
October 3, 2022
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

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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)
  • K241357 — XT3 System (January 22, 2025)
  • 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)