The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Mercury Spinal System.
| Device ID | K083230 |
| 510k Number | K083230 |
| Device Name: | MERCURY SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92010 |
| Contact | Kerri Dimartino |
| Correspondent | Kerri Dimartino SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92010 |
| Product Code | NKB |
| 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 | 2008-11-03 |
| Decision Date | 2008-12-03 |
| Summary: | summary |