The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Spinal Elements Posterior Cervical/thoracic Spinal System.
| Device ID | K120467 |
| 510k Number | K120467 |
| Device Name: | SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92008 |
| Contact | Benjamin A Kimball |
| Correspondent | Benjamin A Kimball SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92008 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-15 |
| Decision Date | 2012-07-30 |
| Summary: | summary |