The following data is part of a premarket notification filed by Nexxt Spine Llc with the FDA for Inertia Pedicle Screw System.
| Device ID | K101278 |
| 510k Number | K101278 |
| Device Name: | INERTIA PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | NEXXT SPINE LLC 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
| Contact | Karen Warden |
| Correspondent | Karen Warden NEXXT SPINE LLC 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-06 |
| Decision Date | 2010-12-20 |
| Summary: | summary |