The following data is part of a premarket notification filed by Nexxt Spine Llc with the FDA for Inertia Pedicle Screw System.
| Device ID | K090984 |
| 510k Number | K090984 |
| Device Name: | INERTIA PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spinal Pedicle 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 | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-07 |
| Decision Date | 2009-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889929018620 | K090984 | 000 |
| 00889929053768 | K090984 | 000 |
| 00889929018460 | K090984 | 000 |
| 00889929018477 | K090984 | 000 |
| 00889929018484 | K090984 | 000 |
| 00889929018491 | K090984 | 000 |
| 00889929018507 | K090984 | 000 |
| 00889929018514 | K090984 | 000 |
| 00889929018521 | K090984 | 000 |
| 00889929018538 | K090984 | 000 |
| 00889929018545 | K090984 | 000 |
| 00889929018552 | K090984 | 000 |
| 00889929018569 | K090984 | 000 |
| 00889929018576 | K090984 | 000 |
| 00889929018583 | K090984 | 000 |
| 00889929018590 | K090984 | 000 |
| 00889929018606 | K090984 | 000 |
| 00889929018613 | K090984 | 000 |
| 00889929017838 | K090984 | 000 |