The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Mercury Spinal System.
| Device ID | K141372 |
| 510k Number | K141372 |
| Device Name: | MERCURY SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SPINAL ELEMENTS, INC. 3115 MELROSE DRIVE STE 200 Carlsbad, CA 92010 |
| Contact | Jason Blain |
| Correspondent | Jason Blain SPINAL ELEMENTS, INC. 3115 MELROSE DRIVE STE 200 Carlsbad, CA 92010 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-27 |
| Decision Date | 2014-08-22 |
| Summary: | summary |