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
FDA 510(k) Regulatory Record - X-Spine Systems, Inc. Orthopedic ✕
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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