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
76-100 of 172
Cleared Sep 25, 2017
INDEPENDENCE® Spacers
K170157 · OVD
Orthopedic · 250d
Cleared Aug 16, 2017
EXCELSIUS GPS
K171651 · OLO
Orthopedic · 72d
Cleared Jul 14, 2017
HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
K171413 · NQW
Orthopedic · 60d
Cleared May 01, 2017
CAPTIVATE™ Compression Screws
K162825 · HWC
Orthopedic · 206d
Cleared Apr 07, 2017
ANTHEM™ Fracture System
K163361 · HRS
Orthopedic · 128d
Cleared Feb 22, 2017
SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers,...
K152022 · MAX
Orthopedic · 582d
Cleared Jan 23, 2017
CONCORD Plus Radiopaque Bone Cement
K162618 · NDN
Orthopedic · 125d
Cleared Sep 29, 2016
ELSA Spacers
K161379 · OVD
Orthopedic · 134d
Cleared Sep 21, 2016
QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
K161591 · NKG
Orthopedic · 104d
Cleared Aug 29, 2016
INDEPENDENCE MIS Spacers
K160597 · OVD
Orthopedic · 180d
Cleared Jul 15, 2016
TransContinental® M Spacers and InterContinental® Plate-Spacers
K161223 · OVD
Orthopedic · 77d
Cleared Apr 13, 2016
SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS...
K143578 · MAX
Orthopedic · 483d
Cleared Mar 16, 2016
SUSTAIN Additional Implants
K151665 · MAX
Orthopedic · 271d
Cleared Feb 03, 2016
Navigation Instruments
K153203 · OLO
Orthopedic · 91d
Cleared Jan 29, 2016
COALITION Spacers
K151939 · OVE
Orthopedic · 199d
Cleared Jun 04, 2015
ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS
K150552 · NKG
Orthopedic · 92d
Cleared Mar 31, 2015
Coalition AGX Plate and Coalition AGX Spacer
K142218 · ODP
Orthopedic · 231d
Cleared Feb 26, 2015
MAGNIFY and MAGNIFY-S Spacers
K142498 · OVD
Orthopedic · 174d
Cleared Jan 30, 2015
CREO Stabilization System
K143633 · NKB
Orthopedic · 39d
Cleared Aug 26, 2014
CONFIRM BIOACTIVE
K133678 · MQV
Orthopedic · 270d
Cleared Jul 01, 2014
ALTERA SPACER
K140411 · MAX
Orthopedic · 133d
Cleared May 21, 2014
SILC FIXATION SYSTEM
K133482 · OWI
Orthopedic · 189d
Cleared Mar 11, 2014
REVERE STABILIZATION SYSTEM
K133350 · NKB
Orthopedic · 132d
Cleared Feb 20, 2014
UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K133567 · KWQ
Orthopedic · 92d
Cleared Dec 30, 2013
MONUMENT SPACERS
K132559 · OVD
Orthopedic · 137d

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