Medical Device Manufacturer · US , Beverly , MA

Spinefrontier, Inc. - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 2007
24
Total
24
Cleared
0
Denied

FDA 510(k) cleared devices by Spinefrontier, Inc. Orthopedic

24 devices
1-24 of 24
Cleared Jun 19, 2020
SpineFrontier Lumbar Interbody Fusion Device System
K193106 · MAX
Orthopedic · 224d
Cleared May 08, 2018
A-CIFT SoloFuse
K172484 · OVE
Orthopedic · 264d
Cleared Jul 17, 2015
A-CIFT SoloFuse
K151198 · OVE
Orthopedic · 73d
Cleared May 13, 2015
SpineFrontier Lumbar Interbody Fusion Device System
K142504 · MAX
Orthopedic · 250d
Cleared Apr 24, 2015
SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
K150017 · OUR
Orthopedic · 109d
Cleared Feb 12, 2015
PedFuse Pedicle Screw System
K143377 · MNH
Orthopedic · 79d
Cleared Nov 25, 2014
ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
K141333 · ODP
Orthopedic · 188d
Cleared Oct 20, 2014
SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
K142026 · ODP
Orthopedic · 87d
Cleared Sep 08, 2014
ARENA-C
K141337 · ODP
Orthopedic · 110d
Cleared May 14, 2014
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
K133153 · MNH
Orthopedic · 209d
Cleared Jan 03, 2014
SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM
K131880 · OVE
Orthopedic · 192d
Cleared Nov 26, 2013
SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
K132740 · NQW
Orthopedic · 84d
Cleared Feb 15, 2013
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
K123164 · MNH
Orthopedic · 129d
Cleared Jul 03, 2012
SPINE FRONTIER INDUS ACP SYSTEM
K121060 · KWQ
Orthopedic · 88d
Cleared Feb 16, 2012
ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K113518 · ODP
Orthopedic · 79d
Cleared Sep 28, 2011
SPINEFRONTIER LUMBAR IBF SYSTEM
K111553 · MAX
Orthopedic · 117d
Cleared Sep 01, 2010
VEGA SPAN SPINOUS PROCESS PLATE SYSTEM
K102020 · KWP
Orthopedic · 44d
Cleared Jun 30, 2010
S-LIF INTERVERTEBRAL BODY FUSION DEVICE
K092815 · MAX
Orthopedic · 289d
Cleared Mar 26, 2010
INDUS ANTERIOR CERVICAL PLATE SYSTEM
K093776 · KWQ
Orthopedic · 108d
Cleared Nov 19, 2009
KRD1 PEDICLE SCREW SYSTEM
K092420 · MNI
Orthopedic · 105d
Cleared Sep 14, 2009
DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031
K091638 · MAX
Orthopedic · 102d
Cleared Feb 20, 2008
INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX
K073232 · KWQ
Orthopedic · 97d
Cleared Jan 16, 2008
CHAMELEON FIXATION SYSTEM
K071420 · MRW
Orthopedic · 239d
Cleared Nov 01, 2007
SPINEFRONTIER DORADO VBR
K072289 · MAX
Orthopedic · 77d
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