The following data is part of a premarket notification filed by Next Orthosurgical with the FDA for Nex-d2 Posterior Fixation System.
| Device ID | K190981 |
| 510k Number | K190981 |
| Device Name: | NEX-D2 Posterior Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Next OrthoSurgical 3270 Corporate View, Suite A Vista, CA 92081 |
| Contact | Sartaj Kaur-hurrle |
| Correspondent | Sartaj Kaur-hurrle Next OrthoSurgical 3270 Corporate View, Suite A Vista, CA 92081 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-15 |
| Decision Date | 2020-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840314155467 | K190981 | 000 |