The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Reline System.
| Device ID | K142499 |
| 510k Number | K142499 |
| Device Name: | Reline System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | NUVASIVE, INCORPORATED 7475 LUSK BOULEVARD San Diego, CA 92121 |
| Contact | Olga Lewis |
| Correspondent | Olga Lewis NUVASIVE, INCORPORATED 7475 LUSK BOULEVARD San Diego, CA 92121 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| 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 | 2014-09-05 |
| Decision Date | 2014-11-19 |
| Summary: | summary |