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
51-71 of 71
Cleared Aug 03, 2006
AVS ASL PEEK SPACER SYSTEM
K061836 · MQP
Orthopedic · 35d
Cleared Jul 27, 2006
XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM
K061854 · NKB
Orthopedic · 27d
Cleared May 25, 2006
STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM
K060506 · MQP
Orthopedic · 87d
Cleared May 19, 2006
XIA TITANIUM AND 4.5 SPINAL SYSTEMS
K060979 · NKB
Orthopedic · 39d
Cleared Apr 13, 2006
MODIFICATION TO XIA 4.5 SPINAL SYSTEM
K060748 · NKB
Orthopedic · 23d
Cleared Mar 06, 2006
XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM
K060361 · NKB
Orthopedic · 21d
Cleared Dec 06, 2005
XIA SPINAL SYSTEM
K053115 · MNI
Orthopedic · 29d
Cleared Nov 16, 2005
STRYKER SPINE TRIO SPINAL FIXATION SYSTEM
K052971 · MNI
Orthopedic · 23d
Cleared Nov 04, 2005
STRYKER SPINE AVS ASL PEEK SPACER
K051205 · MQP
Orthopedic · 177d
Cleared Oct 11, 2005
MODIFICATION TO: XIA 4.5 SPINAL SYSTEM
K052761 · MNI
Orthopedic · 11d
Cleared Sep 21, 2005
MODIFICATION TO: STRYKER SPINE OASYS SYSTEM
K052317 · MNI
Orthopedic · 27d
Cleared Sep 08, 2005
MODIFICATION TO XIA SPINAL SYSTEM
K052181 · KWP
Orthopedic · 29d
Cleared Aug 18, 2005
MODIFICATION TO: XIA STAINLESS STEEL SYSTEM
K051973 · KWP
Orthopedic · 28d
Cleared Jul 27, 2005
XIA 4.5 SPINAL SYSTEM
K050461 · MNH
Orthopedic · 154d
Cleared Apr 11, 2005
STRYKER SPINE AVS PL PEEK SPACER
K050624 · MQP
Orthopedic · 31d
Cleared Mar 02, 2005
STRYKER SPINE TRIO PS
K043180 · MNH
Orthopedic · 105d
Cleared Feb 16, 2005
TECHTONIX SYSTEM
K050189 · KWP
Orthopedic · 20d
Cleared Feb 11, 2005
STRYKER SPINE AVS TL PEEK SPACER
K042571 · MQP
Orthopedic · 143d
Cleared Jan 12, 2005
MODIFICATION TO XIA SPINAL SYSTEM
K043473 · KWP
Orthopedic · 27d
Cleared Aug 05, 2004
STRYKER SPINE VERTEBRAL SPACER
K040731 · MQP
Orthopedic · 136d
Cleared Apr 16, 2004
REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM
K040261 · KWQ
Orthopedic · 72d
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