Medical Device Manufacturer · US , Allendale , NJ

Stryker Spine

73 submissions · 72 cleared · Since 2004
73
Total
72
Cleared
0
Denied

Stryker Spine — FDA 510(k) Submissions

Stryker Spine has submitted 73 FDA 510(k) premarket notifications since 2004, of which 72 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Thoracolumbosacral Pedicle Screw System, Spinal Vertebral Body Replacement Device, Appliance, Fixation, Spinal Interlaminal, Orthosis, Spinal Pedicle Fixation, Appliance, Fixation, Spinal Intervertebral Body . Use the specialty filter in the sidebar to narrow results.

73 devices
1–25 of 73
OZARK Cervical Plate System; PYRENEES? Cervical Plate System; EVEREST? Spinal System; MESA? Spinal System; MESA? Small Stature Spinal System; CASPIAN? Spinal System; DENALI? Spinal System; DENALI? MI Spinal System; YUKON OCT Spinal System; Xia? 3 Spinal System; K2M Patient Specific; CASCADIA? Interbody System; CAYMAN? Plate System; CAYMAN? Plate System-MI
K242361 · KWQ Appliance, Fixation,... · Orthopedic
Nov 2024 90d
Vitoss? BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss? BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma? Bioactive Bone Graft Substitute,Vitoss? BA2X Bioactive Bone Graft Substitute, Vitoss? Bioactive Bone Graft Substitute Pack,Vitoss? Bioactive Bone Graft Substitute, Vitoss? Foam Bone Graft Substitute, Vitoss? Bone Graft Substitute Filled Canister, Vitoss? Bone Graft Substitute, Vitoss? Bone Graft Substitute - Synthetic Cancellous Chips
K242280 · MQV Filler, Bone Void,... · Orthopedic
Aug 2024 27d
XIA? 4.5 Spinal System, XIA? 4.5 Cortical Trajectory, XIA? 3 Spinal System, Serrato? Spinal System, XIA? Growth Rod Conversion Set, XIA? II Spinal System, XIA? Precision System, XIA? Anterior, Diapason? Spinal System, Opus? Spinal System, Radius? Spinal System, Mantis? Spinal System, Mantis? Redux, Trio? & Trio+ Spinal Fixation System, ES2? Spinal System, ES2? Augmentable Spinal System, Oasys? Occipito-Cervico-Thoracic System, Nile? Proximal Fixation Spinal System, Nile? Alternative Fi
K222684 · NKB Thoracolumbosacral... · Orthopedic
Jun 2023 275d
Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer
K221490 · ODP Intervertebral Fusion... · Orthopedic
Feb 2023 267d
Navigated Spine Instruments
K203205 · OLO Orthopedic Stereotaxic... · Orthopedic
Mar 2021 144d
Stryker Xia 3 Power Adaptor
K200666 · NKB Thoracolumbosacral... · Orthopedic
Apr 2020 41d
Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage
K183249 · MAX Intervertebral Fusion... · Orthopedic
Jul 2019 246d
VLIFT-s Vertebral Body Replacement System
K183071 · PLR Spinal Vertebral Body... · Orthopedic
Jan 2019 66d
Tritanium PL Cage
K181014 · MAX Intervertebral Fusion... · Orthopedic
Jul 2018 92d
Tritanium C Anterior Cervical Cage
K171496 · ODP Intervertebral Fusion... · Orthopedic
Sep 2017 107d
Ascential IBD PEEKc Spacer
K161407 · ODP Intervertebral Fusion... · Orthopedic
Jul 2016 56d
AERO -C Cervical Cage System
K152532 · ODP Intervertebral Fusion... · Orthopedic
Dec 2015 106d
MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL
K133188 · NKB Thoracolumbosacral... · Orthopedic
Dec 2013 61d
UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)
K132968 · PEK Spinous Process Plate · Orthopedic
Nov 2013 56d
ES2 SPINAL SYSTEM MODEL 48280XXXX
K122845 · NKB Thoracolumbosacral... · Orthopedic
Dec 2012 81d
LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
K122637 · FST Light, Surgical, Fiberoptic · General & Plastic Surgery
Nov 2012 64d
ANCHOR-L LUMBAR CAGE
K120869 · OVD Intervertebral Fusion... · Orthopedic
Oct 2012 217d
XIA 3 SPINAL SYSTEM
K113666 · NKB Thoracolumbosacral... · Orthopedic
Aug 2012 259d
AVS AS PEEK SPACER
K120486 · ODP Intervertebral Fusion... · Orthopedic
Aug 2012 185d
ESCALATE LAMINOPLASTY SYSTEM
K113802 · NQW Orthosis, Spine, Plate,... · Orthopedic
Apr 2012 115d
OASYS SPINAL SYSTEM
K111719 · KWP Appliance, Fixation,... · Orthopedic
Jan 2012 213d
AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
K110419 · GXZ Electrode, Needle · Neurology
Jul 2011 164d
AVS ANCHOR-C CERVICAL CAGE SYSTEM
K102606 · OVE Intervertebral Fusion... · Orthopedic
Apr 2011 224d
MODIFICATION TO: OASYS SYSTEM
K101183 · KWP Appliance, Fixation,... · Orthopedic
Nov 2010 195d
MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM
K102235 · NKB Thoracolumbosacral... · Orthopedic
Aug 2010 15d
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