The following data is part of a premarket notification filed by Spinal Elements Inc. with the FDA for Mercury Spinal System.
| Device ID | K151215 |
| 510k Number | K151215 |
| Device Name: | Mercury Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Spinal Elements Inc. 3115 Melrose Dr.,Suite 200 Carlsbad, CA 92010 |
| Contact | Julie Lamothe |
| Correspondent | Julie Lamothe Spinal Elements Inc. 3115 Melrose Dr.,Suite 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-06 |
| Decision Date | 2015-06-03 |
| Summary: | summary |