Orthopedic Fixation Pin

FDA 510(k) K191803 · Tinavi (Anhui) Medical Technologies Co., Ltd.

Substantially Equivalent

510(k) numberK191803

Submission

Device name
Orthopedic Fixation Pin
Applicant
Tinavi (Anhui) Medical Technologies Co., Ltd.
Hefei, CN
Received
July 3, 2019
Decision date
April 14, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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
K192768Temporary Fixation PinsJDW · Traditional Eisertech, LLC12/26/2019SE
K182171SMV Scientific K-Wire and PinsJDW · Traditional Summit Medventures10/25/2018SE

Questions and answers

When was Orthopedic Fixation Pin cleared by the FDA?

Orthopedic Fixation Pin (K191803) received a 510(k) decision of Substantially Equivalent on April 14, 2020, 286 days after the submission was received.

What is the product code of K191803?

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