Medical Device Manufacturer · US , Carlsbad , CA

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

93 submissions · 93 cleared · Since 2005
93
Total
93
Cleared
0
Denied
93 devices
51-75 of 93
Cleared Sep 25, 2018
OsseoScrew System
K181980 · NKB
Orthopedic · 62d
Cleared Aug 21, 2018
ATEC Cervical Spacer System
K181435 · ODP
Orthopedic · 81d
Cleared Aug 09, 2018
Kodiak Spinal Fixation System
K181677 · NKB
Orthopedic · 44d
Cleared Jul 25, 2018
ATEC ALIF Spacer System
K181453 · MAX
Orthopedic · 54d
Cleared May 31, 2018
ATEC Universal Spacer System
K180480 · PHM
Orthopedic · 97d
Cleared Nov 30, 2017
Solanas® Posterior Stabilization System
K173522 · NKB
Orthopedic · 16d
Cleared Aug 24, 2016
XYcor® Expandable Spinal Spacer System
K160646 · MAX
Orthopedic · 170d
Cleared Jun 10, 2016
Arsenal Spinal Fixation System
K161363 · NKB
Orthopedic · 24d
Cleared Apr 29, 2016
Alphatec Navigation Instruments
K153603 · OLO
Orthopedic · 134d
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

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