The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Range Spinal System, Small Stature.
| Device ID | K122877 |
| 510k Number | K122877 |
| Device Name: | RANGE SPINAL SYSTEM, SMALL STATURE |
| 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 | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-19 |
| Decision Date | 2013-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857055124 | K122877 | 000 |
| 10888857053687 | K122877 | 000 |
| 10888857053724 | K122877 | 000 |
| 10888857053755 | K122877 | 000 |
| 10888857210264 | K122877 | 000 |
| 10888857210271 | K122877 | 000 |
| 10888857210288 | K122877 | 000 |
| 10888857210295 | K122877 | 000 |
| 10888857052468 | K122877 | 000 |
| 10888857052567 | K122877 | 000 |
| 10888857052598 | K122877 | 000 |
| 10888857052642 | K122877 | 000 |
| 10888857053823 | K122877 | 000 |
| 10888857054950 | K122877 | 000 |
| 10888857054981 | K122877 | 000 |
| 10888857055025 | K122877 | 000 |
| 10888857055056 | K122877 | 000 |
| 10888857053656 | K122877 | 000 |