The following data is part of a premarket notification filed by Spineology Inc with the FDA for Spineology Navigation Instruments.
| Device ID | K182345 |
| 510k Number | K182345 |
| Device Name: | Spineology Navigation Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Spineology Inc 7800 Third Street N., Suite 600 St. Paul, MN 55128 |
| Contact | Karen Roche |
| Correspondent | Karen Roche Spineology Inc 7800 Third Street N., Suite 600 St. Paul, MN 55128 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-28 |
| Decision Date | 2018-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7401610033 | K182345 | 000 |