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
151-172 of 172
Cleared May 28, 2008
REVERE UNIPLANAR SCREWS
K081195 · NKB
Orthopedic · 30d
Cleared Jan 18, 2008
PATRIOT SPACERS
K072970 · MAX
Orthopedic · 88d
Cleared Jan 18, 2008
PATRIOT SPACERS: COLONIAL ACDF
K072991 · ODP
Orthopedic · 87d
Cleared Jan 03, 2008
H-LINK INTEGRATED ROD
K073517 · NKB
Orthopedic · 20d
Cleared Dec 20, 2007
MICROFUSE BONE VOID FILLER
K071187 · MQV
Orthopedic · 234d
Cleared Dec 13, 2007
BEACON STABILIZATION SYSTEM
K073172 · NKB
Orthopedic · 30d
Cleared Oct 04, 2007
NIKO CORPECTOMY SPACER
K072465 · MQP
Orthopedic · 30d
Cleared Apr 19, 2007
MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM
K070775 · KWQ
Orthopedic · 29d
Cleared Dec 19, 2006
CITADEL ANTERIOR LUMBAR PLATE SYSTEM
K062836 · KWQ
Orthopedic · 90d
Cleared Sep 06, 2006
GATEWAY THORACOLUMBAR PLATE SYSTEM
K062407 · KWQ
Orthopedic · 20d
Cleared Jul 20, 2006
REVERE STABILIZATION SYSTEM
K061202 · NKB
Orthopedic · 80d
Cleared Jun 08, 2006
RETAIN RADIOLUCENT SPACER
K061380 · MQP
Orthopedic · 21d
Cleared May 10, 2006
XPAND RADIOLUCENT CORPECTOMY SPACER
K060665 · MQP
Orthopedic · 57d
Cleared Aug 17, 2005
PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES
K052069 · KWP
Orthopedic · 16d
Cleared Jul 21, 2005
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
K050391 · KWP
Orthopedic · 155d
Cleared May 26, 2005
XPAND CORPECTOMY SPACER
K050850 · MQP
Orthopedic · 52d
Cleared Jan 14, 2005
CONCORD Radiopaque Bone Cement
K042168 · NDN
Orthopedic · 158d
Cleared Nov 22, 2004
MODIFICATION TO PROTEX STABILIZATION SYSTEM
K042953 · NKB
Orthopedic · 27d
Cleared Jun 17, 2004
ASSURE ANTERIOR CERVICAL PLATE SYSTEM
K040721 · KWQ
Orthopedic · 90d
Cleared May 20, 2004
PROTEX STABILIZATION SYSTEM
K040442 · MNH
Orthopedic · 90d
Cleared Mar 23, 2004
SUSTAIN RADIOLUCENT SPACER
K040284 · MQP
Orthopedic · 46d
Cleared Jun 27, 2003
SUSTAIN SPACER
K031302 · MQP
Orthopedic · 64d

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