The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Spinal Elements Cervical Intervertebral Body Fusion System.
| Device ID | K122771 |
| 510k Number | K122771 |
| Device Name: | SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92010 |
| Contact | Benjamin A Kimball |
| Correspondent | Benjamin A Kimball SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92010 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-10 |
| Decision Date | 2013-01-10 |
| Summary: | summary |