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FDA 510(k) Applications Submitted by CHARLENE BRUMBAUGH
FDA 510(k) Number
Submission Date
Device Name
Applicant
K170119
01/13/2017
Calix Lumbar Spinal Implant System
X-Spine Systems, Inc.
K180153
01/19/2018
X-spine Cortical Bone Screw System
X-spine Systems, Inc.
K031872
06/17/2003
ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING]
ADAC LABORATORIES
K033735
11/28/2003
VANTAGE PRO ATTENUATION CORRECTION DEVICE
ADAC LABORATORIES
K173832
12/18/2017
InTiceÖ-C Porous Ti Cervical Interbody System
X-Spine Systems, Inc.
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