The following data is part of a premarket notification filed by Spineology Inc. with the FDA for Spineology Navigation Instruments.
| Device ID | K172518 |
| 510k Number | K172518 |
| Device Name: | Spineology Navigation Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Spineology Inc. 7800 3rd Street N., Suite 600 Scandia, MN 55128 |
| Contact | Jacqueline Hauge |
| Correspondent | Jacqueline Hauge Spineology Inc. 7800 3rd Street N., Suite 600 Scandia, MN 55128 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-21 |
| Decision Date | 2018-01-05 |
| Summary: | summary |