The following data is part of a premarket notification filed by Theken Spine, Llc with the FDA for Coral Spinal System.
| Device ID | K120047 |
| 510k Number | K120047 |
| Device Name: | CORAL SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | THEKEN SPINE, LLC 1153 Medina Rd. Medina, OH 44256 |
| Contact | Dale Davison |
| Correspondent | Dale Davison THEKEN SPINE, LLC 1153 Medina Rd. Medina, OH 44256 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MHI |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-06 |
| Decision Date | 2012-02-03 |
| Summary: | summary |