The following data is part of a premarket notification filed by K2m, Inc with the FDA for Everest Spinal System.
| Device ID | K151216 |
| 510k Number | K151216 |
| 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 | 2015-05-06 |
| Decision Date | 2015-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857274037 | K151216 | 000 |
| 10888857158191 | K151216 | 000 |
| 10888857158184 | K151216 | 000 |
| 10888857158115 | K151216 | 000 |
| 10888857158085 | K151216 | 000 |
| 10888857158061 | K151216 | 000 |
| 10888857271487 | K151216 | 000 |
| 10888857271470 | K151216 | 000 |
| 10888857271449 | K151216 | 000 |
| 10888857271432 | K151216 | 000 |
| 10888857271425 | K151216 | 000 |
| 10888857158207 | K151216 | 000 |
| 10888857158214 | K151216 | 000 |
| 10888857273979 | K151216 | 000 |
| 10888857158306 | K151216 | 000 |
| 10888857158290 | K151216 | 000 |
| 10888857158283 | K151216 | 000 |
| 10888857158276 | K151216 | 000 |
| 10888857158269 | K151216 | 000 |
| 10888857158252 | K151216 | 000 |
| 10888857158245 | K151216 | 000 |
| 10888857158238 | K151216 | 000 |
| 10888857158221 | K151216 | 000 |
| 10888857271395 | K151216 | 000 |