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510(k) K960023

KIRSHNER WIRES (K-WIRE) & STEINMANN PINS by Promex, Inc. — Product Code JDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1996
Date Received
January 2, 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 Promex, Inc.

  • K023450 — BIOPSY SITE TISSUE MARKER DEVICE (December 19, 2002)
  • K022634 — CO-AXIAL INTRODUCER NEEDLE (November 6, 2002)
  • K010400 — VACUUM ASSISTED CORE BIOPSY DEVICE (July 24, 2001)
  • K011270 — AUTOMATED CORE BIOPSY DEVICE (June 22, 2001)
  • K001132 — BONE BIOPSY NEEDLE (May 1, 2000)
  • K994272 — AUTOMATED CORE BIOPSY DEVICE (January 7, 2000)
  • K993435 — MANUAL BONE MARROW BIOPSY DEVICE (December 6, 1999)
  • K973184 — PROSTATE SEEDING NEEDLE (November 21, 1997)
  • K972865 — PROMEX ENT TISSUE REMOVAL SYSTEM (September 29, 1997)
  • K961078 — AUTOMATED VITRECTOMY DEVICE (June 14, 1996)

Other clearances for product code JDW

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  • K241357 — XT3 System (January 22, 2025)
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  • K213874 — MAVERICK External Fixation System (February 11, 2022)
  • K211508 — Steinmann Pins and Kirschner Wires (October 5, 2021)
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  • K191803 — Orthopedic Fixation Pin (April 14, 2020)
  • K192768 — Temporary Fixation Pins (December 26, 2019)