The following data is part of a premarket notification filed by Spineology Inc. with the FDA for Spineology Navigation Instruments.
| Device ID | K213876 |
| 510k Number | K213876 |
| Device Name: | Spineology Navigation Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Spineology Inc. 7800 3rd Street North, Suite 600 Saint Paul, MN 55128 |
| Contact | Andrew Adams |
| Correspondent | Andrew Adams Spineology Inc. 7800 3rd Street North, Suite 600 Saint Paul, 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 | 2021-12-13 |
| Decision Date | 2022-08-05 |