The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Revere Stabilization System.
| Device ID | K122226 |
| 510k Number | K122226 |
| Device Name: | REVERE 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 | 2012-07-26 |
| Decision Date | 2012-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095980875 | K122226 | 000 |
| 00889095038538 | K122226 | 000 |
| 00889095038545 | K122226 | 000 |
| 00889095038552 | K122226 | 000 |
| 00889095038569 | K122226 | 000 |
| 00889095038576 | K122226 | 000 |
| 00889095039580 | K122226 | 000 |
| 00889095039597 | K122226 | 000 |
| 00889095980851 | K122226 | 000 |
| 00889095980868 | K122226 | 000 |
| 00889095038521 | K122226 | 000 |