The following data is part of a premarket notification filed by Nexxt Spine Llc with the FDA for Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate And Screws.
| Device ID | K141376 |
| 510k Number | K141376 |
| Device Name: | INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | NEXXT SPINE LLC PO BOX 566 Chesterland, OH 44026 |
| Contact | Karen E Warden |
| Correspondent | Karen E Warden NEXXT SPINE LLC PO BOX 566 Chesterland, OH 44026 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MAX |
| Subsequent Product Code | MNI |
| Subsequent Product Code | MQP |
| Subsequent Product Code | MRW |
| Subsequent Product Code | ODP |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-27 |
| Decision Date | 2014-06-26 |
| Summary: | summary |