Medical Device Manufacturer · US , Stillwater , MN

Spineology, Inc. - FDA 510(k) Cleared Devices

54 submissions · 51 cleared · Since 1999
54
Total
51
Cleared
1
Denied
53 devices
26-50 of 53
Cleared Mar 08, 2017
Rampart(TM) T Lumbar Interbody Fusion Device
K163409 · MAX
Orthopedic · 93d
Cleared Jan 30, 2017
Elite Expandable Interbody Fusion Device
K162879 · MAX
Orthopedic · 108d
Cleared Oct 18, 2016
Rampart D Lumbar Interbody Fusion Device
K160074 · MAX
Orthopedic · 278d
Cleared Jul 15, 2016
Threshold™ Pedicular Fixation System
K161694 · NKB
Orthopedic · 25d
Cleared Jul 14, 2016
Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion...
K160906 · MAX
Orthopedic · 104d
Cleared May 26, 2016
Threshold Pedicular Fixation System, Palisade Pedicular Fixation System
K160980 · NKB
Orthopedic · 49d
Cleared Feb 23, 2016
Palisade Pedicular Fixation System
K153323 · NKB
Orthopedic · 97d
Cleared Feb 04, 2016
Rampart A Lumbar Interbody Fusion Device
K153082 · MAX
Orthopedic · 104d
Cleared Sep 02, 2015
Fortress Pedicular Fixation System
K152148 · NKB
Orthopedic · 30d
Cleared Jul 22, 2015
Rampart-T Interbody Fusion System
K151020 · MAX
Orthopedic · 97d
Cleared Dec 18, 2014
Threshold Pedicular Fixation System
K143403 · NKB
Orthopedic · 20d
Cleared Sep 10, 2014
VIA SPINOUS PROCESS FIXATION SYSTEM
K142213 · PEK
Orthopedic · 29d
Cleared Apr 23, 2014
FORTRESS PEDICLE SCREW SYSTEM
K140010 · NKB
Orthopedic · 111d
Cleared Jan 09, 2014
RAMPART-L
K133371 · MAX
Orthopedic · 69d
Cleared Sep 16, 2013
RAMPART-O, RAMPART-T
K132053 · MAX
Orthopedic · 75d
Cleared May 30, 2013
RAMPART O
K131216 · MAX
Orthopedic · 30d
Cleared Mar 25, 2013
RAMPART O AND RAMPART P
K130396 · MAX
Orthopedic · 34d
Cleared Mar 22, 2013
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K123652 · MAX
Orthopedic · 115d
Cleared Feb 07, 2013
SPINEOLOGY SPINOUS PROCESS PLATE
K123232 · KWP
Orthopedic · 114d
Cleared Jun 13, 2012
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K121129 · MAX
Orthopedic · 61d
Cleared Feb 29, 2012
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE
K120293 · MAX
Orthopedic · 29d
Cleared Jan 26, 2012
SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE
K113030 · MAX
Orthopedic · 106d
Cleared Sep 26, 2011
SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE
K111880 · MAX
Orthopedic · 87d
Cleared Jun 13, 2011
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K110933 · MAX
Orthopedic · 70d
Cleared Nov 09, 2009
SPINEOLOGY FACET SCREW
K092464 · MRW
Orthopedic · 90d
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