The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Revere Stabilization System.
| Device ID | K061202 | 
| 510k Number | K061202 | 
| Device Name: | REVERE STABILIZATION SYSTEM | 
| Classification | Thoracolumbosacral Pedicle Screw System | 
| Applicant | GLOBUS MEDICAL INC. 303 SCHELL LN. Phoenixville, PA 19460 | 
| Contact | Kelly Baker | 
| Correspondent | Kelly Baker GLOBUS MEDICAL INC. 303 SCHELL LN. Phoenixville, PA 19460  | 
| 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 | 2006-05-01 | 
| Decision Date | 2006-07-20 | 
| Summary: | summary |