The following data is part of a premarket notification filed by K2m Inc. with the FDA for Everest Spinal System.
| Device ID | K181188 |
| 510k Number | K181188 |
| Device Name: | EVEREST Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | K2M Inc. 600 Hope Pkwy. SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Karen E. Warden BackRoads Consulting, Inc P.O Box 566 Chesterland, OH 44026 -0566 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-03 |
| Decision Date | 2018-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857413443 | K181188 | 000 |