The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Range Spinal System, Small Strature Components.
| Device ID | K123412 |
| 510k Number | K123412 |
| Device Name: | RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-06 |
| Decision Date | 2013-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857051812 | K123412 | 000 |
| 10888857051799 | K123412 | 000 |
| 10888857051775 | K123412 | 000 |
| 10888857051751 | K123412 | 000 |
| 10888857051744 | K123412 | 000 |
| 10888857051737 | K123412 | 000 |
| 10888857008748 | K123412 | 000 |
| 10888857008724 | K123412 | 000 |
| 10888857008700 | K123412 | 000 |