The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Sapphire Anterior Cervical Plate System.
| Device ID | K101848 |
| 510k Number | K101848 |
| Device Name: | SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| 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 | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-01 |
| Decision Date | 2010-10-14 |
| Summary: | summary |