The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Caliber Spacer.
Device ID | K102293 |
510k Number | K102293 |
Device Name: | CALIBER SPACER |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
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 | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-13 |
Decision Date | 2011-01-05 |
Summary: | summary |