Medical Device Manufacturer · US , Audubon , PA

Globus Medical, Inc. - FDA 510(k) Cleared Devices

172 submissions · 169 cleared · Since 2003
172
Total
169
Cleared
0
Denied
172 devices
51-75 of 172
Cleared Apr 09, 2019
ExcelsiusGPS
K190653 · OLO
Orthopedic · 26d
Cleared Apr 08, 2019
CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®
K182375 · NKB
Orthopedic · 220d
Cleared Apr 05, 2019
CROSSWAY Spinal Access System
K190598 · HRX
Orthopedic · 29d
Cleared Feb 06, 2019
SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments,...
K183119 · OUR
Orthopedic · 89d
Cleared Jan 29, 2019
AQrate Robotic Assistance System
K182000 · HAW
Orthopedic · 187d
Cleared Dec 18, 2018
REVEL Spacers
K180909 · ODP
Orthopedic · 256d
Cleared Dec 06, 2018
PATRIOT® Lumbar Spacers, SUSTAIN® Spacers
K181357 · MAX
Orthopedic · 198d
Cleared Nov 06, 2018
ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate...
K181846 · KWQ
Orthopedic · 118d
Cleared Oct 22, 2018
ANTHEM Fracture System
K180554 · HRS
Orthopedic · 235d
Cleared Sep 19, 2018
FORTIFY Corpectomy Spacers
K173982 · MQP
Orthopedic · 264d
Cleared Jun 29, 2018
CREO® Stabilization System, REVERE® Stabilization System
K181068 · PGM
Orthopedic · 67d
Cleared Jun 25, 2018
Navigation Instruments
K180690 · OLO
Orthopedic · 101d
Cleared May 23, 2018
PATRIOT COLONIAL Spacer, SUSTAIN Spacer
K173722 · ODP
Orthopedic · 169d
Cleared May 21, 2018
AERIAL™ Interspinous Fixation
K180817 · PEK
Orthopedic · 53d
Cleared Apr 02, 2018
CREO® Stabilization System
K180210 · NKB
Orthopedic · 68d
Cleared Mar 27, 2018
FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO®...
K172269 · PML
Orthopedic · 242d
Cleared Mar 07, 2018
ALVUE Balloon Dilation System
K171939 · GCJ
General & Plastic Surgery · 252d
Cleared Mar 07, 2018
SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
K180156 · PEK
Orthopedic · 47d
Cleared Jan 12, 2018
ARBOR External Fixation System
K172438 · KTT
Orthopedic · 154d
Cleared Dec 29, 2017
AUTOBAHN Nailing System
K171108 · HSB
Orthopedic · 259d
Cleared Dec 21, 2017
FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers,...
K171848 · MAX
Orthopedic · 183d
Cleared Dec 20, 2017
COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS,...
K173115 · ODP
Orthopedic · 82d
Cleared Nov 13, 2017
ANTHEM Fracture System
K173166 · HRS
Orthopedic · 45d
Cleared Nov 09, 2017
FORTIFY Corpectomy Spacers
K162315 · MQP
Orthopedic · 448d
Cleared Oct 26, 2017
SILC® Fixation System
K172417 · OWI
Orthopedic · 77d

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