The following data is part of a premarket notification filed by Mikron Makina Sanayi Ticaret Co. Ltd. with the FDA for Mikron Spinal Fixation System.
| Device ID | K171497 |
| 510k Number | K171497 |
| Device Name: | Mikron Spinal Fixation System |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | Mikron Makina Sanayi Ticaret Co. Ltd. Agac Isleri Sanayi Sitesi 1372. Sokak No: 31-Ostim Ankara, TR 06378 |
| Contact | Mesut Kose |
| Correspondent | Mesut Köse Mikron Makina Sanayi Ticaret Co. Ltd. Agac Isleri Sanayi Sitesi 1372. Sokak No: 31-Ostim Ankara, TR 06378 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-22 |
| Decision Date | 2017-10-12 |
| Summary: | summary |