The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Range (denali And Mesa) Spinal Systems.
| Device ID | K181119 |
| 510k Number | K181119 |
| Device Name: | Range (Denali And Mesa) Spinal Systems |
| Classification | Thoracolumbosacral Pedicle Screw System |
| 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 | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-27 |
| Decision Date | 2018-06-26 |
| Summary: | summary |