The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Mosaic Devices.
| Device ID | K071833 |
| 510k Number | K071833 |
| Device Name: | MOSAIC DEVICES |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92008 |
| Contact | Kerri Dimartino |
| Correspondent | Kerri Dimartino SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92008 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-03 |
| Decision Date | 2007-10-23 |
| Summary: | summary |