The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Range Spinal System.
| Device ID | K100851 |
| 510k Number | K100851 |
| Device Name: | RANGE SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-26 |
| Decision Date | 2010-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857052277 | K100851 | 000 |
| 10888857006973 | K100851 | 000 |
| 10888857007000 | K100851 | 000 |
| 10888857007031 | K100851 | 000 |
| 10888857007062 | K100851 | 000 |
| 10888857007093 | K100851 | 000 |
| 10888857007116 | K100851 | 000 |
| 10888857007130 | K100851 | 000 |
| 10888857007161 | K100851 | 000 |
| 10888857025110 | K100851 | 000 |
| 10888857025134 | K100851 | 000 |
| 10888857025141 | K100851 | 000 |
| 10888857025158 | K100851 | 000 |
| 10888857025165 | K100851 | 000 |
| 10888857025172 | K100851 | 000 |
| 10888857025189 | K100851 | 000 |
| 10888857025196 | K100851 | 000 |
| 10888857052260 | K100851 | 000 |
| 10888857006959 | K100851 | 000 |