The following data is part of a premarket notification filed by Spinal Elements Inc with the FDA for Spinal Elements Navigated Instruments.
| Device ID | K190881 |
| 510k Number | K190881 |
| Device Name: | Spinal Elements Navigated Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Spinal Elements Inc 3115 Melrose Dr. Suite 200 Carlsbad, CA 92010 |
| Contact | Julie Lamothe |
| Correspondent | Julie Lamothe Spinal Elements Inc 3115 Melrose Dr. Suite 200 Carlsbad, CA 92010 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-04 |
| Decision Date | 2019-12-19 |