Medical Device Manufacturer · CH , Geneva

Spineart

44 submissions · 44 cleared · Since 2008
44
Total
44
Cleared
0
Denied

Spineart — FDA 510(k) Submissions

Spineart has submitted 44 FDA 510(k) premarket notifications since 2008, of which 44 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Intervertebral Fusion Device With Bone Graft, Lumbar, Thoracolumbosacral Pedicle Screw System, Orthosis, Spondylolisthesis Spinal Fixation, Intervertebral Fusion Device With Bone Graft, Cervical, Orthosis, Spinal Pedicle Fixation . Use the specialty filter in the sidebar to narrow results.

44 devices
1–25 of 44
PERLA? TL System; TEKTONA? HV US Bone Cement
K230774 · PML Bone Cement, Posterior... · Orthopedic
Jun 2023 94d
PERLA? TL Posterior Osteosynthesis System
K213470 · NKB Thoracolumbosacral... · Orthopedic
Jan 2022 85d
SPINEART Navigation Instrument System
K210472 · OLO Orthopedic Stereotaxic... · Orthopedic
Mar 2021 30d
PERLA? TL posterior osteosynthesis system
K203506 · NKB Thoracolumbosacral... · Orthopedic
Jan 2021 46d
PERLA TL Posterior Osteosynthesis System
K203222 · NKB Thoracolumbosacral... · Orthopedic
Dec 2020 45d
PERLA? Posterior Occipito-Cervico-Thoracic Fixation System
K200571 · NKG Posterior Cervical Screw... · Orthopedic
May 2020 58d
Tryptik Ti
K200312 · ODP Intervertebral Fusion... · Orthopedic
Apr 2020 60d
PERLA? TL posterior osteosynthesis system
K193396 · NKB Thoracolumbosacral... · Orthopedic
Feb 2020 61d
SCARLET AL-T
K192993 · OVD Intervertebral Fusion... · Orthopedic
Jan 2020 89d
Juliet? Ti LL Lumbar Interbody Device
K190877 · OVD Intervertebral Fusion... · Orthopedic
May 2019 55d
SCARLET? AC-T Secured Anterior Cervical Cage
K190322 · ODP Intervertebral Fusion... · Orthopedic
Mar 2019 19d
Perla? Posterior Cervico-Thoracic Fixation System
K190071 · NKG Posterior Cervical Screw... · Orthopedic
Feb 2019 41d
Scarlet AL-T
K181818 · OVD Intervertebral Fusion... · Orthopedic
Oct 2018 92d
Juliet Ti
K181203 · MAX Intervertebral Fusion... · Orthopedic
Jun 2018 52d
TRYPTIK2 C-Plate Anterior Cervical Plate System
K171797 · KWQ Appliance, Fixation,... · Orthopedic
Feb 2018 255d
Juliet Ti LL
K173702 · MAX Intervertebral Fusion... · Orthopedic
Jan 2018 30d
SCARLET AC-T
K172065 · ODP Intervertebral Fusion... · Orthopedic
Sep 2017 84d
ROMEO? 2 Posterior Osteosynthesis System
K172101 · NKB Thoracolumbosacral... · Orthopedic
Sep 2017 76d
JULIET? LL Lateral Lumbar Cage
K161888 · MAX Intervertebral Fusion... · Orthopedic
Sep 2016 63d
Juliet? Ti
K153621 · MAX Intervertebral Fusion... · Orthopedic
Jul 2016 210d
TRYPTIK2C-plate Anterior Cervical Plate System
K153042 · KWQ Appliance, Fixation,... · Orthopedic
Mar 2016 161d
Perla Posterior Cervico-Thoracic Fixation system
K153386 · NKG Posterior Cervical Screw... · Orthopedic
Jan 2016 63d
OTELO LL
K151104 · GAD Retractor · General & Plastic Surgery
Jan 2016 257d
Romeo posterior osteosynthesis system
K151695 · MNH Orthosis,... · Orthopedic
Sep 2015 79d
SCARLET? AC-T Secured Anterior Cervical Cage
K143214 · OVE Intervertebral Fusion... · Orthopedic
Feb 2015 105d
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