The following data is part of a premarket notification filed by K2m, Inc with the FDA for Range/denali/mesa Spinal System.
| Device ID | K150325 |
| 510k Number | K150325 |
| Device Name: | Range/Denali/Mesa Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | K2M, Inc 751 Miller Drive SE 20175 Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M, Inc 751 Miller Drive SE 20175 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-09 |
| Decision Date | 2015-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857051843 | K150325 | 000 |
| 10888857051195 | K150325 | 000 |
| 10888857051171 | K150325 | 000 |
| 10888857051164 | K150325 | 000 |
| 10888857051140 | K150325 | 000 |
| 10888857051133 | K150325 | 000 |
| 10888857051119 | K150325 | 000 |
| 10888857051102 | K150325 | 000 |
| 10888857051089 | K150325 | 000 |
| 10888857051072 | K150325 | 000 |
| 10888857051201 | K150325 | 000 |
| 10888857051225 | K150325 | 000 |
| 10888857051232 | K150325 | 000 |
| 10888857051621 | K150325 | 000 |
| 10888857051614 | K150325 | 000 |
| 10888857051355 | K150325 | 000 |
| 10888857051348 | K150325 | 000 |
| 10888857051324 | K150325 | 000 |
| 10888857051317 | K150325 | 000 |
| 10888857051294 | K150325 | 000 |
| 10888857051287 | K150325 | 000 |
| 10888857051263 | K150325 | 000 |
| 10888857051256 | K150325 | 000 |