The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Mojave Expandable Interbody System.
| Device ID | K193203 |
| 510k Number | K193203 |
| Device Name: | MOJAVE Expandable Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | K2M, Inc. 600 Hope Parkway SE Leesburg, VA 21075 |
| Contact | Oonagh Lahiff |
| Correspondent | Megan Callanan Stryker 2 Pearl Court Allendale, NJ 07401 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-20 |
| Decision Date | 2020-02-18 |