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
34 devices
26-34 of 34
Cleared Nov 24, 2010
AXLE INTERSPINOUS FUSION SYSTEM
K101471 · KWP
Orthopedic · 181d
Cleared May 21, 2010
FIXCET SPINAL FACET SCREW SYSTEM
K100154 · MRW
Orthopedic · 121d
Cleared Jan 22, 2010
ACP4 SPINAL IMPLANT SYSTEM
K092360 · KWQ
Orthopedic · 171d
Cleared Jul 30, 2009
FORTEX PEDICLE SCREW SYSTEM
K090224 · MNH
Orthopedic · 181d
Cleared Apr 20, 2009
CALIX SPINAL IMPLANT SYSTEM
K083637 · ODP
Orthopedic · 132d
Cleared Jan 28, 2008
BUTREX BUTTRESS PLATING SYSTEM
K072943 · KWQ
Orthopedic · 103d
Cleared Sep 14, 2007
CAPLESS LI PEDICLE SCREW SYSTEM
K072282 · MNH
Orthopedic · 29d
Cleared Dec 12, 2005
CAPLESS PEDICLE SCREW SYSTEM
K052847 · MNI
Orthopedic · 66d
Cleared Oct 21, 2005
SPIDER CERVICAL PLATING (SCP) SYSTEM
K052292 · KWQ
Orthopedic · 59d
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