The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Patriot Spacers.
Device ID | K072970 |
510k Number | K072970 |
Device Name: | PATRIOT SPACERS |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403 |
Contact | Kelly J Baker |
Correspondent | Kelly J Baker GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-22 |
Decision Date | 2008-01-18 |
Summary: | summary |