Skip to the page
Get started free

Data / Medical devices / Turkey / Mikron Makina Sanayi Ve Ticaret Ltd. Sti.

Mikron Makina Sanayi Ve Ticaret Ltd. Sti.: FDA-registered device maker in Ivedik Ankara, Turkey, 3 510(k) clearances

Mikron Makina Sanayi Ve Ticaret Ltd. Sti. is registered with the FDA (registration 3010646402) in Ivedik Ankara, Turkey. It lists 26 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 13, 2026. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Mikron Makina Sanayi Ve Ticaret Ltd. Sti.
FDA registration number
3010646402
Address
Agac Isleri Sanayi Sitesi 1372 Sokak No. 31, Ivedik Ankara, Turkey, 06378
Owner or operator
Mikron Makina Sanayi ve Ticaret Ltd. Sti. (10045988)
Roles
Manufacturer
First device listed
December 15, 2021
Registered through
2026
Brand names listed
MIKRON TRAUMA BONE PLATE& SCREW SYSTEM, MSFX- PPRPS4530 / MSFX MIKRON POLAR DUAL LEAD SPON POLYAXIAL SCREW 4.5X30 MM + SET SCREW, MSFX- PPRPS4535 / MSFX MIKRON POLAR DUAL LEAD SPON POLYAXIAL SCREW 4.5X35 MM + SET SCREW, MSFX- PPRPS4540 / MSFX MIKRON POLAR DUAL LEAD SPON POLYAXIAL SCREW 4.5X40 MM + SET SCREW, MSFX- PPRPS4545 / MSFX MIKRON POLAR DUAL LEAD SPON POLYAXIAL SCREW 4.5X45 MM + SET SCREW, MSFX- PPRPS5530 / MSFX MIKRON POLAR DUAL LEAD SPON POLYAXIAL SCREW 5.5X30 MM + SET SCREW, MSFX- PPRPS5535 / MSFX MIKRON POLAR DUAL LEAD SPON POLYAXIAL SCREW 5.5X35 MM + SET SCREW, MSFX- PPRPS5540 / MSFX MIKRON POLAR DUAL LEAD SPON POLYAXIAL SCREW 5.5X40 MM + SET SCREW and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Fixation, Spinal Intervertebral BodyLYQ1Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal InterlaminalKWP2Manufactureraccessdata.fda.gov
AwlHWJ1Manufactureraccessdata.fda.gov
BenderHXW1Manufactureraccessdata.fda.gov
CountersinkHWW1Manufactureraccessdata.fda.gov
Cutter, WireHXZ1Manufactureraccessdata.fda.gov
ExtractorHWB1Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Manufactureraccessdata.fda.gov
Guide, Drill, LigamentLXI1Manufactureraccessdata.fda.gov
ImpactorHWA1Manufactureraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Manufactureraccessdata.fda.gov
Instrument, CompressionHWN1Manufactureraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Manufactureraccessdata.fda.gov
ReamerHTO1Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufactureraccessdata.fda.gov
Tap, BoneHWX1Manufactureraccessdata.fda.gov
TemplateHWT1Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Manufactureraccessdata.fda.gov
TrephineHWK1Manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Manufactureraccessdata.fda.gov
WrenchHXC1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 13, 2026K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMHRSSubstantially EquivalentMikron Makina San. ve Tic. Ltd. Sti.accessdata.fda.gov
December 19, 2025K252781MSFX MIKRON PEEK CAGESODPSubstantially EquivalentMikron Makina Sanayi VE Tic. Ltd. Sti.accessdata.fda.gov
September 30, 2024K241657MSFX MIKRON SPINAL FIXATION SYSTEMNKBSubstantially EquivalentMikron Makina Sanayi VE Ticaret Ltd. Sti.accessdata.fda.gov

Compare with other makers

Updated August 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.