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 |