The following data is part of a premarket notification filed by Next Orthosurgical with the FDA for Vertiform Posterior Fixation System.
| Device ID | K141291 |
| 510k Number | K141291 |
| Device Name: | VERTIFORM POSTERIOR FIXATION SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | NEXT ORTHOSURGICAL 3270 Corporate Vw Ste A Vista, CA 92081 |
| Contact | Huan Tran |
| Correspondent | Huan Tran NEXT ORTHOSURGICAL 3270 Corporate Vw Ste A Vista, CA 92081 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-19 |
| Decision Date | 2014-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840314116567 | K141291 | 000 |
| 00840314139115 | K141291 | 000 |
| 00840314116574 | K141291 | 000 |
| 00840314115560 | K141291 | 000 |
| 00840314114310 | K141291 | 000 |
| 00840314113085 | K141291 | 000 |
| 00840314111814 | K141291 | 000 |
| 00840314107848 | K141291 | 000 |