The following data is part of a premarket notification filed by Nexxt Spine Llc with the FDA for Nexxt Spine Navigation System.
| Device ID | K220291 |
| 510k Number | K220291 |
| Device Name: | NEXXT SPINE NAVIGATION System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Nexxt Spine LLC 14425 Bergen Blvd, Suite B Noblesville, IN 46060 |
| Contact | Andy Elsbury |
| Correspondent | Karen E Warden BackRoads Consulting Inc. PO Box 566 Chesterland, OH 44026 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-01 |
| Decision Date | 2022-03-31 |