FDA.reportPublic FDA data

510(k) K241357

Device
XT3 System
Applicant
Biodynamik, Inc.
510(k) number
K241357
Product code
JDW
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-22
Date received
2024-05-14
Regulation
888.3040
Classification name
Pin, Fixation, Threaded
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Johnny Chen
Address
11 Orchard Rd. Suite 107 Lake Forest CA US 92630 92630

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JDW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.2026-02-10
K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC2025-10-29
K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.2022-12-08
K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.2022-02-11
K211508Steinmann Pins and Kirschner WiresStryker GmbH2021-10-05
K210784Extended HA Half PinsSmith & Nephew, Inc.2021-04-02
K200933Syntec Non-Sterile Steinmann Pins SystemSyntec Scientific Corporation2020-05-05
K191803Orthopedic Fixation PinTinavi (Anhui) Medical Technologies Co., Ltd.2020-04-14
K192768Temporary Fixation PinsEisertech, LLC2019-12-26
K182171SMV Scientific K-Wire and PinsSummit Medventures2018-10-25
K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.2017-02-13
K150661ST.A.R. 90 F4 External Fixation Screws With HydroxyapatiteCitieffe S.R.L.2015-07-07
K132820VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRESVilex, Inc.2014-07-23
K140875OPTOSSOL COMPRESSION DEVICE SYSTEMGenossis, LLC2014-05-30
K131459AAP K-WIRE, STEINMANN PIN, CERCLAGE WIREAap Implantate AG2013-10-17