Medical Device Manufacturer · US , Centerville , OH

X-Spine Systems, Inc. - FDA 510(k) Cleared Devices

34 submissions · 34 cleared · Since 2005
34
Total
34
Cleared
0
Denied

X-Spine Systems, Inc. has 34 FDA 510(k) cleared orthopedic devices. Based in Centerville, US.

Historical record: 34 cleared submissions from 2005 to 2018.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - X-Spine Systems, Inc.
34 devices
1-12 of 34
Cleared May 17, 2018
InTice™-C Porous Ti Cervical Interbody System
K173832 · ODP
Orthopedic · 150d
Cleared Mar 15, 2018
X-spine Cortical Bone Screw System
K180153 · NKB
Orthopedic · 55d
Cleared Sep 29, 2017
Calix Lumbar Spinal Implant System
K170119 · MAX
Orthopedic · 259d
Cleared Aug 28, 2017
IRIX-A Lumbar Integrated Fusion System
K171567 · OVD
Orthopedic · 90d
Cleared Aug 01, 2017
Calix-C Cervical Interbody Spacer
K171075 · ODP
Orthopedic · 112d
Cleared Jul 06, 2017
Spider Cervical Plating System
K170224 · KWQ
Orthopedic · 162d
Cleared Mar 22, 2017
Butrex Lumbar Buttress Plating System
K170530 · KWQ
Orthopedic · 28d
Cleared Nov 17, 2016
Xsert Lumbar Expandable Interbody System
K160959 · MAX
Orthopedic · 226d
Cleared Nov 07, 2016
Irix-C Cervical Integrated Fusion System
K162944 · OVE
Orthopedic · 17d
Cleared May 05, 2016
Certex Spinal Fixation System
K160428 · NKG
Orthopedic · 79d
Cleared Mar 15, 2016
Xspan Laminoplasty Fixation System
K160114 · NQW
Orthopedic · 56d
Cleared Sep 25, 2015
X-spine Pedicle Screw System
K152132 · MNI
Orthopedic · 56d
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