The following data is part of a premarket notification filed by K2m, Inc. with the FDA for K2m Growing Spine System.
| Device ID | K161028 |
| 510k Number | K161028 |
| Device Name: | K2M Growing Spine System |
| Classification | Growing Rod System |
| Applicant | K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M, Inc. 600 Hope Parkway Southeast Leesburg, VA 20175 |
| Product Code | PGM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-12 |
| Decision Date | 2016-07-22 |
| Summary: | summary |