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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889929045756 | K220291 | 000 |
| 00889929052327 | K220291 | 000 |
| 00889929052310 | K220291 | 000 |
| 00889929052303 | K220291 | 000 |
| 00889929052297 | K220291 | 000 |
| 00889929052280 | K220291 | 000 |
| 00889929052273 | K220291 | 000 |
| 00889929052266 | K220291 | 000 |
| 00889929052259 | K220291 | 000 |
| 00889929052242 | K220291 | 000 |
| 00889929052235 | K220291 | 000 |
| 00889929052228 | K220291 | 000 |
| 00889929052211 | K220291 | 000 |
| 00889929052204 | K220291 | 000 |
| 00889929052198 | K220291 | 000 |
| 00889929053522 | K220291 | 000 |
| 00889929052334 | K220291 | 000 |
| 00889929052341 | K220291 | 000 |
| 00889929052358 | K220291 | 000 |
| 00889929045749 | K220291 | 000 |
| 00889929045732 | K220291 | 000 |
| 00889929045725 | K220291 | 000 |
| 00889929045718 | K220291 | 000 |
| 00889929045701 | K220291 | 000 |
| 00889929045695 | K220291 | 000 |
| 00889929053430 | K220291 | 000 |
| 00889929053003 | K220291 | 000 |
| 00889929052990 | K220291 | 000 |
| 00889929052419 | K220291 | 000 |
| 00889929052402 | K220291 | 000 |
| 00889929052396 | K220291 | 000 |
| 00889929052389 | K220291 | 000 |
| 00889929052372 | K220291 | 000 |
| 00889929052365 | K220291 | 000 |
| 00889929053515 | K220291 | 000 |