The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Range/denali/mesa Spinal System.
| Device ID | K171832 |
| 510k Number | K171832 |
| Device Name: | Range/Denali/Mesa Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | K2M, Inc. 600 Hope Parkway SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M, Inc. 600 Hope Parkway Southeast 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 | 2017-06-20 |
| Decision Date | 2017-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857267152 | K171832 | 000 |
| 10888857182653 | K171832 | 000 |
| 10888857182646 | K171832 | 000 |
| 10888857182639 | K171832 | 000 |
| 10888857182622 | K171832 | 000 |
| 10888857182615 | K171832 | 000 |
| 10888857182608 | K171832 | 000 |
| 10888857182592 | K171832 | 000 |
| 10888857182585 | K171832 | 000 |
| 10888857182578 | K171832 | 000 |
| 10888857182561 | K171832 | 000 |
| 10888857182660 | K171832 | 000 |
| 10888857182677 | K171832 | 000 |
| 10888857267145 | K171832 | 000 |
| 10888857267138 | K171832 | 000 |
| 10888857267121 | K171832 | 000 |
| 10888857182745 | K171832 | 000 |
| 10888857182738 | K171832 | 000 |
| 10888857182721 | K171832 | 000 |
| 10888857182714 | K171832 | 000 |
| 10888857182707 | K171832 | 000 |
| 10888857182691 | K171832 | 000 |
| 10888857182684 | K171832 | 000 |
| 10888857182554 | K171832 | 000 |