Medical Device Manufacturer · US , Chesterland , OH

Nexxt Spine, LLC

22 submissions · 22 cleared · Since 2009
22
Total
22
Cleared
0
Denied

Nexxt Spine, LLC — FDA 510(k) Submissions

Nexxt Spine, LLC has submitted 22 FDA 510(k) premarket notifications since 2009, of which 22 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, Appliance, Fixation, Spinal Intervertebral Body, Intervertebral Fusion Device With Integrated Fixation, Cervical, Orthosis, Spinal Pedicle Fixation . Use the specialty filter in the sidebar to narrow results.

22 devices
1–22 of 22
INERTIA? CONNEXX? Modular Pedicle Screw System
K231799 · NKB Thoracolumbosacral... · Orthopedic
Jul 2023 30d
INERTIA CONNEXX Modular Pedicle Screw System
K221905 · NKB Thoracolumbosacral... · Orthopedic
Jul 2022 28d
NEXXT SPINE NAVIGATION System
K220291 · OLO Orthopedic Stereotaxic... · Orthopedic
Mar 2022 58d
NEXXT MATRIXX Stand Alone ALIF System
K202230 · OVD Intervertebral Fusion... · Orthopedic
Dec 2020 130d
STRUXXURE?-L and STRUXXURE?-A Plate System
K202192 · KWQ Appliance, Fixation,... · Orthopedic
Sep 2020 43d
NEXXT MATRIXX System
K200969 · MAX Intervertebral Fusion... · Orthopedic
May 2020 38d
NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System
K200543 · OVE Intervertebral Fusion... · Orthopedic
Mar 2020 20d
NEXXT MATRIXX System
K193412 · PLR Spinal Vertebral Body... · Orthopedic
Feb 2020 77d
Nexxt Matrixx System
K193370 · MAX Intervertebral Fusion... · Orthopedic
Jan 2020 47d
TrellOss?-L MPF
K192687 · MAX Intervertebral Fusion... · Orthopedic
Jan 2020 105d
Nexxt Matrixx System
K191408 · MAX Intervertebral Fusion... · Orthopedic
Jul 2019 43d
NEXXT MATRIXX Stand Alone Cervical System
K190546 · OVE Intervertebral Fusion... · Orthopedic
May 2019 87d
Saxxony? Posterior Cervical Thoracic System
K182508 · NKG Posterior Cervical Screw... · Orthopedic
Nov 2018 62d
Matrixx System
K171140 · ODP Intervertebral Fusion... · Orthopedic
Aug 2017 126d
Inertia Pedicle Screw and Deformity Correxxion System
K153453 · NKB Thoracolumbosacral... · Orthopedic
Apr 2016 148d
INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
K141376 · MNH Orthosis,... · Orthopedic
Jun 2014 30d
STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
K133475 · KWQ Appliance, Fixation,... · Orthopedic
Dec 2013 37d
INERTIA MIS PEDICLE SCREW SYSTEM
K132412 · MNI Orthosis, Spinal Pedicle... · Orthopedic
Oct 2013 69d
FACET FIXX
K131417 · MRW System, Facet Screw... · Orthopedic
Jul 2013 57d
HONOUR SPACER SYSTEM
K120345 · ODP Intervertebral Fusion... · Orthopedic
Jun 2012 131d
INERTIA PEDICLE SCREW SYSTEM
K101278 · MNH Orthosis,... · Orthopedic
Dec 2010 228d
INERTIA PEDICLE SCREW SYSTEM
K090984 · MNI Orthosis, Spinal Pedicle... · Orthopedic
Jun 2009 84d
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