Mikron Makina Sanayi Ve Ticaret Ltd. Sti.
Country not established FDA establishment FEI 3010646402
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
What Mikron Makina Sanayi Ve Ticaret Ltd. Sti. makes
The company manufactures spinal fixation systems, including polyaxial pedicle screws, set screws, and longitudinal rods for surgical stabilization of the spine. These products are designed for internal fixation in orthopedic and spinal surgeries, supporting structural integrity during bone healing.
The portfolio includes devices classified as Class II and Class IIb under EU regulations, with listings in the EUDAMED database and FDA’s 510(k) registry. The company is based in Turkey.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Msfx Mikron Spinal Fixation System Ref K241657
Regimes: 510(k) Registry: 510(k)MSFX Mikron Cervical Anterior Plate System Ref K240484
Registry: 510(k)
Company details
- FDA FEI number
- 3010646402
- Address
- Agac Isleri Sanayi Sitesi, Ivedik Ankara
Frequently asked questions
How many devices does MIKRON MAKINA SANAYI VE TICARET LTD. STI. have in the registry?
The registry currently lists 3 devices for MIKRON MAKINA SANAYI VE TICARET LTD. STI.. Devices recorded under merged duplicate company entries are counted once.
Which registries list MIKRON MAKINA SANAYI VE TICARET LTD. STI.'s devices?
Among its 3 most recently registered devices, MIKRON MAKINA SANAYI VE TICARET LTD. STI. has devices listed in FDA 510(k) (3 devices).
What risk classes do MIKRON MAKINA SANAYI VE TICARET LTD. STI.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for MIKRON MAKINA SANAYI VE TICARET LTD. STI.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from MIKRON MAKINA SANAYI VE TICARET LTD. STI. in the registry?
The most recently registered devices listed for MIKRON MAKINA SANAYI VE TICARET LTD. STI. include MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS, MSFX MIKRON SPINAL FIXATION SYSTEM and MSFX Mikron Cervical Anterior Plate System.