The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Range Spinal System.
| Device ID | K121630 |
| 510k Number | K121630 |
| Device Name: | RANGE SPINAL SYSTEM |
| Classification | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| 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 | OSH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-04 |
| Decision Date | 2012-09-11 |
| Summary: | summary |