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 |