The following data is part of a premarket notification filed by K2m, Inc with the FDA for Everest Spinal System.
| Device ID | K142360 |
| 510k Number | K142360 |
| Device Name: | Everest Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | K2M, Inc 751 Miller Drive SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M, Inc 751 Miller Drive SE Leesburg, VA 20175 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-25 |
| Decision Date | 2015-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857039742 | K142360 | 000 |