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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840314119964 | K161499 | 000 |
| 00840314120083 | K161499 | 000 |
| 00840314120090 | K161499 | 000 |
| 00840314120106 | K161499 | 000 |
| 00840314120113 | K161499 | 000 |
| 00840314120120 | K161499 | 000 |
| 00840314120137 | K161499 | 000 |
| 00840314120144 | K161499 | 000 |
| 00840314120151 | K161499 | 000 |
| 00840314120076 | K161499 | 000 |
| 00840314120069 | K161499 | 000 |
| 00840314120052 | K161499 | 000 |
| 00840314119971 | K161499 | 000 |
| 00840314119988 | K161499 | 000 |
| 00840314119995 | K161499 | 000 |
| 00840314120007 | K161499 | 000 |
| 00840314120014 | K161499 | 000 |
| 00840314120021 | K161499 | 000 |
| 00840314120038 | K161499 | 000 |
| 00840314120045 | K161499 | 000 |
| 00840314120168 | K161499 | 000 |
| 00840314120175 | K161499 | 000 |
| 00840314120298 | K161499 | 000 |
| 00840314120304 | K161499 | 000 |
| 00840314120311 | K161499 | 000 |
| 00840314120328 | K161499 | 000 |
| 00840314120335 | K161499 | 000 |
| 00840314120342 | K161499 | 000 |
| 00840314120359 | K161499 | 000 |
| 00840314120366 | K161499 | 000 |
| 00840314120281 | K161499 | 000 |
| 00840314120274 | K161499 | 000 |
| 00840314120267 | K161499 | 000 |
| 00840314120182 | K161499 | 000 |
| 00840314120199 | K161499 | 000 |
| 00840314120205 | K161499 | 000 |
| 00840314120212 | K161499 | 000 |
| 00840314120229 | K161499 | 000 |
| 00840314120236 | K161499 | 000 |
| 00840314120243 | K161499 | 000 |
| 00840314120250 | K161499 | 000 |
| 00840314120373 | K161499 | 000 |