The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Shilla Growth Guidance System.
| Device ID | K140750 |
| 510k Number | K140750 |
| Device Name: | SHILLA GROWTH GUIDANCE SYSTEM |
| Classification | Growing Rod System |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lee Grant |
| Correspondent | Lee Grant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| 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 | 2014-03-25 |
| Decision Date | 2014-07-17 |
| Summary: | summary |