Kirschner (K-Wire), Steinman Pins

FDA 510(k) K945670 · Brasseler USA I, L.P.

Substantially Equivalent

510(k) numberK945670

Submission

Device name
Kirschner (K-Wire), Steinman Pins
Applicant
Brasseler USA I, L.P.
Savannah, GA, US
Received
November 18, 1994
Decision date
March 7, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JDW – Pin, Fixation, Threaded
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code JDW

510(k)DeviceApplicantDecision
K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmJDW · Special Biodynamik, Inc.02/10/2026SE
K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemJDW · Traditional Meduloc, LLC10/29/2025SE
K241357XT3 SystemJDW · Traditional Biodynamik, Inc.01/22/2025SE
K223112MAVERICK Mini External Fixation SystemJDW · Traditional Smith & Nephew, Inc.12/08/2022SE
K213874MAVERICK External Fixation SystemJDW · Traditional Smith & Nephew, Inc.02/11/2022SE
K211508Steinmann Pins and Kirschner WiresJDW · Traditional Stryker GmbH10/05/2021SE
K210784Extended HA Half PinsJDW · Special Smith & Nephew, Inc.04/02/2021SE
K200933Syntec Non-Sterile Steinmann Pins SystemJDW · Special Syntec Scientific Corporation05/05/2020SE
K191803Orthopedic Fixation PinJDW · Traditional Tinavi (Anhui) Medical Technologies Co., Ltd.04/14/2020SE
K192768Temporary Fixation PinsJDW · Traditional Eisertech, LLC12/26/2019SE

More from Eisertech, LLC

510(k)DeviceDecision
K030172Small High Speed Motor Drill SystemHBE · Traditional 04/03/2003SE
K983223Dental Sterlization Tray/CassetteFRG · Traditional 01/14/1999SE
K9551402.0 X 6MM ScrewDZL · Traditional 01/05/1996SE

Questions and answers

When was Kirschner (K-Wire), Steinman Pins cleared by the FDA?

Kirschner (K-Wire), Steinman Pins (K945670) received a 510(k) decision of Substantially Equivalent on March 7, 1995, 109 days after the submission was received.

What is the product code of K945670?

The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.