The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Revere 6.35 Stabilization System.
Device ID | K091782 |
510k Number | K091782 |
Device Name: | REVERE 6.35 STABILIZATION SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
Contact | Kelly J Baker |
Correspondent | Kelly J Baker 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 | 2009-06-17 |
Decision Date | 2009-08-13 |
Summary: | summary |