The following data is part of a premarket notification filed by Mikron Makina Sanayi Ve Ticaret Ltd Sti with the FDA for Mikron Spinal Fixation System, Polyxial Pedicle Screws, Set Screws, Longitudinal Rods.
| Device ID | K130073 |
| 510k Number | K130073 |
| Device Name: | MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | MIKRON MAKINA SANAYI VE TICARET LTD STI 80 LEICESTER WAY Chesapeake City, MD 21915 |
| Contact | Omar Diker |
| Correspondent | Omar Diker MIKRON MAKINA SANAYI VE TICARET LTD STI 80 LEICESTER WAY Chesapeake City, MD 21915 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-11 |
| Decision Date | 2013-12-16 |
| Summary: | summary |