The following data is part of a premarket notification filed by Next Orthosurgical with the FDA for Vertiform Posterior Fixation System.
| Device ID | K161499 |
| 510k Number | K161499 |
| Device Name: | VertiForm Posterior Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | NEXT ORTHOSURGICAL 3270 CORPORATE VIEW, SUITE A Vista, CA 92081 |
| Contact | Ellen Yarnall |
| Correspondent | Ellen Yarnall NEXT ORTHOSURGICAL 3270 CORPORATE VIEW, SUITE A Vista, CA 92081 |
| Product Code | NKB |
| Subsequent Product Code | MKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-01 |
| Decision Date | 2016-07-29 |
| Summary: | summary |