The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Range Spinal System, Unit Rod.
| Device ID | K120899 |
| 510k Number | K120899 |
| Device Name: | RANGE SPINAL SYSTEM, UNIT ROD |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | K2M, INC. 751 MILLER DR., S.E., SUITE F1 Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M, INC. 751 MILLER DR., S.E., SUITE F1 Leesburg, VA 20175 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-26 |
| Decision Date | 2012-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857018242 | K120899 | 000 |
| 10888857006621 | K120899 | 000 |
| 10888857006645 | K120899 | 000 |
| 10888857006669 | K120899 | 000 |
| 10888857006676 | K120899 | 000 |
| 10888857006706 | K120899 | 000 |
| 10888857006713 | K120899 | 000 |
| 10888857006737 | K120899 | 000 |
| 10888857018174 | K120899 | 000 |
| 10888857018181 | K120899 | 000 |
| 10888857018198 | K120899 | 000 |
| 10888857018204 | K120899 | 000 |
| 10888857018211 | K120899 | 000 |
| 10888857018228 | K120899 | 000 |
| 10888857018235 | K120899 | 000 |
| 10888857006614 | K120899 | 000 |