The following data is part of a premarket notification filed by Nexxt Spine Llc with the FDA for Inertia Connexx Modular Pedicle Screw System.
| Device ID | K221905 |
| 510k Number | K221905 |
| Device Name: | INERTIA CONNEXX Modular Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| 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 | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-30 |
| Decision Date | 2022-07-28 |