The following data is part of a premarket notification filed by K2m with the FDA for Mojave Expandable Interbody System.
| Device ID | K163364 |
| 510k Number | K163364 |
| Device Name: | MOJAVE Expandable Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | K2M 600 Hope Parkway SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M 600 Hope Parkway SE Leesburg, VA 20175 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-30 |
| Decision Date | 2017-03-15 |
| Summary: | summary |