The following data is part of a premarket notification filed by K2m, Inc. with the FDA for K2m Expandable Interbody System.
| Device ID | K180777 |
| 510k Number | K180777 |
| Device Name: | K2M Expandable Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | K2M, Inc. 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 | 2018-03-26 |
| Decision Date | 2018-08-03 |
| Summary: | summary |