The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Everest Spinal System.
| Device ID | K103440 |
| 510k Number | K103440 |
| Device Name: | EVEREST SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-23 |
| Decision Date | 2011-03-17 |
| Summary: | summary |