The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Revere 4.5 Stabilization System.
Device ID | K113395 |
510k Number | K113395 |
Device Name: | REVERE 4.5 STABILIZATION SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
Contact | Sarah M Fitzgerald |
Correspondent | Sarah M Fitzgerald 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 |
Subsequent Product Code | OSH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Se - With Limitations (SESU) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-11-17 |
Decision Date | 2012-06-14 |
Summary: | summary |