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510(k) K961920

CROSS PIN by Medicinelodge, Inc. — Product Code JDW

K961920 is an FDA 510(k) premarket notification submitted by Medicinelodge, Inc. for the device "CROSS PIN". The FDA issued a decision of Substantially Equivalent on September 17, 1996. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Medicinelodge, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1996
Date Received
May 17, 1996
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 Medicinelodge, Inc.

  • K072525 — ZIPKNOT, MODEL 1017-3000 (October 5, 2007)
  • K051488 — MEDICINELODGE ZIPKNOT (July 27, 2005)
  • K962705 — MLI MODULAR STAPLE (October 1, 1996)
  • K961905 — MEDICINELODGE, INC. SET SCREW (August 6, 1996)
  • K962194 — MLI SOFT TISSUE SCREW & WASHER SYSTEM (July 30, 1996)
  • K961025 — EXPANDED BODY SUTURE (April 15, 1996)
  • K953350 — MLI INTERFERENCE SCREW (January 30, 1996)

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)
  • 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)

FDA data resources