The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Beacon Stabilization System.
| Device ID | K121922 |
| 510k Number | K121922 |
| Device Name: | BEACON STABILIZATION SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Contact | Meriam Youssef |
| Correspondent | Meriam Youssef GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| 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 | 2012-07-02 |
| Decision Date | 2012-07-26 |
| Summary: | summary |