Medical Device Manufacturer · US , Allendale , NJ

Stryker Spine - FDA 510(k) Cleared Devices

73 submissions · 72 cleared · Since 2004
73
Total
72
Cleared
0
Denied
71 devices
26-50 of 71
Cleared Jul 08, 2010
MODIFICATION TO:RADIUS SPINAL SYSTEM
K101144 · NKB
Orthopedic · 76d
Cleared Apr 12, 2010
MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM
K100737 · NKB
Orthopedic · 28d
Cleared Mar 18, 2010
MODIFICATION TO: OASYS SYSTEM
K093670 · MNH
Orthopedic · 111d
Cleared Dec 03, 2009
XIA 4.5 SPINAL SYSTEM
K092605 · NKB
Orthopedic · 101d
Cleared Sep 25, 2009
VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX,...
K091946 · MQP
Orthopedic · 87d
Cleared Sep 25, 2009
MANTIS REDUX SPINAL SYSTEM
K092631 · NKB
Orthopedic · 30d
Cleared Jun 24, 2009
XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD
K091291 · NKB
Orthopedic · 54d
Cleared Apr 01, 2009
XIA 3 SPINAL SYSTEM
K083393 · NKB
Orthopedic · 135d
Cleared Oct 07, 2008
RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601
K082608 · NKB
Orthopedic · 29d
Cleared Jun 09, 2008
THOR ANTERIOR PLATING SYSTEM
K080773 · KWQ
Orthopedic · 82d
Cleared Apr 30, 2008
XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS
K080928 · NKB
Orthopedic · 28d
Cleared Mar 06, 2008
AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX
K073470 · MAX
Orthopedic · 87d
Cleared Feb 14, 2008
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
K080143 · MNI
Orthopedic · 23d
Cleared Feb 13, 2008
THOR ANTERIOR PLATING SYSTEM
K073437 · KWQ
Orthopedic · 69d
Cleared Oct 05, 2007
MODIFICATION TO OASYS SYSTEM
K072568 · KWP
Orthopedic · 23d
Cleared Aug 27, 2007
STRYKER SPINE XIA III SPINAL SYSTEM
K071373 · NKB
Orthopedic · 103d
Cleared Jul 13, 2007
DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM
K070631 · NKB
Orthopedic · 128d
Cleared Mar 22, 2007
ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
K063430 · KWQ
Orthopedic · 129d
Cleared Dec 11, 2006
XIA STAINLESS STEEL SPINAL SYSTEM
K063428 · NKB
Orthopedic · 28d
Cleared Nov 22, 2006
RADIUS SPINAL SYSTEM
K062270 · NKB
Orthopedic · 107d
Cleared Oct 24, 2006
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
K062853 · MNI
Orthopedic · 29d
Cleared Oct 11, 2006
TRIO + SPINAL SYSTEM
K062698 · MNI
Orthopedic · 30d
Cleared Sep 19, 2006
MANTIS SPINAL SYSTEM
K061813 · MNH
Orthopedic · 84d
Cleared Aug 18, 2006
REFLEX HYBRID ACP SYSTEM
K062310 · KWQ
Orthopedic · 10d
Cleared Aug 16, 2006
AVS PL PEEK SPACER SYSTEM
K062132 · MQP
Orthopedic · 21d
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