Medical Device Manufacturer · US , Carlsbad , CA

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

92 submissions · 92 cleared · Since 2005
92
Total
92
Cleared
0
Denied
84 devices
51-75 of 84
Cleared Dec 30, 2015
Arsenal Spinal Fixation System
K152968 · NKB
Orthopedic · 83d
Cleared May 22, 2015
Battalion Universal Spacer System
K143740 · MAX
Orthopedic · 143d
Cleared Jan 05, 2015
Arsenal Spinal Fixation System
K143149 · NKB
Orthopedic · 63d
Cleared Mar 13, 2014
ARSENAL SPINAL FIXATION SYSTEM
K133221 · NKB
Orthopedic · 146d
Cleared May 21, 2013
SOLANAS POSTERIOR STABILIZATION SYSTEM
K131119 · NKB
Orthopedic · 29d
Cleared Apr 18, 2013
EPICAGE INTERBODY FUSION DEVICE
K130548 · MAX
Orthopedic · 45d
Cleared Mar 05, 2013
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
K123993 · OVD
Orthopedic · 69d
Cleared Feb 14, 2013
ILLICO MIS POSTERIOR FIXATION SYSTEM
K123623 · NKB
Orthopedic · 83d
Cleared Nov 28, 2012
ILLICO FS FACET FIXATION SYSTEM
K123218 · MRW
Orthopedic · 44d
Cleared Jan 25, 2012
XENON(TM) PEDICLE SCREW SYSTEM
K111634 · NKB
Orthopedic · 226d
Cleared Nov 28, 2011
RAPTOR FACET FIXATION SYSTEM
K110170 · MRW
Orthopedic · 312d
Cleared Jul 12, 2011
SOLANAS AVALON POSTERIOR FIXATION SYSTEM
K111076 · NKB
Orthopedic · 85d
Cleared Jun 02, 2011
BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM
K103205 · KWP
Orthopedic · 213d
Cleared Mar 30, 2011
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM
K102402 · OVD
Orthopedic · 218d
Cleared Nov 05, 2010
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
K102820 · KWQ
Orthopedic · 38d
Cleared Jul 21, 2010
ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM
K101255 · KWQ
Orthopedic · 78d
Cleared Jun 18, 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K100685 · KWP
Orthopedic · 100d
Cleared Feb 17, 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K100138 · MNI
Orthopedic · 29d
Cleared Dec 23, 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K093077 · MNI
Orthopedic · 84d
Cleared Jul 08, 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K091189 · MNI
Orthopedic · 76d
Cleared Jul 07, 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K090779 · MNI
Orthopedic · 106d
Cleared May 19, 2009
GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM
K090425 · MAX
Orthopedic · 89d
Cleared Apr 29, 2009
ROC LUMBAR PLATING SYSTEM
K090228 · MNH
Orthopedic · 89d
Cleared Apr 22, 2009
NOVEL ALIF SPINAL SPACER SYSTEM
K090782 · MAX
Orthopedic · 30d
Cleared Sep 19, 2008
NOVEL CERVICAL SPINAL SPACER SYSTEM
K081730 · ODP
Orthopedic · 93d

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