Medical Device Manufacturer · US , Pear , MS

Precision Spine, Inc.

24 submissions · 24 cleared · Since 2014
24
Total
24
Cleared
0
Denied

Precision Spine, Inc. — FDA 510(k) Submissions

Precision Spine, Inc. has submitted 24 FDA 510(k) premarket notifications since 2014, of which 24 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Thoracolumbosacral Pedicle Screw System, Appliance, Fixation, Spinal Intervertebral Body, Orthopedic Stereotaxic Instrument, Spinous Process Plate, Posterior Cervical Screw System . Use the specialty filter in the sidebar to narrow results.

24 devices
1–24 of 24
Dakota LP System
K250769 · ODP Intervertebral Fusion... · Orthopedic
Nov 2025 256d
Reform Pedicle Screw System
K242297 · NKB Thoracolumbosacral... · Orthopedic
Dec 2024 137d
S-COMP Reform? POCT Navigation Instruments
K231229 · OLO Orthopedic Stereotaxic... · Orthopedic
May 2023 27d
E-GPS Navigated Instruments
K220862 · OLO Orthopedic Stereotaxic... · Orthopedic
Jul 2022 112d
Dakota ALIF System
K213118 · OVD Intervertebral Fusion... · Orthopedic
Apr 2022 186d
AccuFit Lateral 2-Hole Plate
K220324 · KWQ Appliance, Fixation,... · Orthopedic
Mar 2022 41d
ShurFit Lumbar Interbody System
K212075 · MAX Intervertebral Fusion... · Orthopedic
Dec 2021 159d
Dakota ALIF Plate System
K212937 · KWQ Appliance, Fixation,... · Orthopedic
Nov 2021 50d
NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
K203129 · OVE Intervertebral Fusion... · Orthopedic
Jan 2021 85d
Precision Spine Navigation Instrumentation
K181606 · OLO Orthopedic Stereotaxic... · Orthopedic
Sep 2019 465d
Reform? POCT System
K172495 · NKG Posterior Cervical Screw... · Orthopedic
Apr 2018 236d
Reform? Midline Cortical Screw System
K173130 · NKB Thoracolumbosacral... · Orthopedic
Dec 2017 81d
ShurFit 2C Lumbar Interbody Fusion System
K171657 · MAX Intervertebral Fusion... · Orthopedic
Aug 2017 67d
ShurFit CpTi-HA ACIF Interbody Fusion System
K161809 · ODP Intervertebral Fusion... · Orthopedic
Dec 2016 158d
AccuFit Lateral Plate System
K162211 · KWQ Appliance, Fixation,... · Orthopedic
Nov 2016 112d
Reform? POCT System
K162300 · NKG Posterior Cervical Screw... · Orthopedic
Nov 2016 98d
Precision Spine Interspinous Plate System
K160568 · PEK Spinous Process Plate · Orthopedic
May 2016 65d
Reform Pedicle Screw System
K151422 · NKB Thoracolumbosacral... · Orthopedic
Aug 2015 85d
Precision Spine Interspinous Plate System
K151863 · PEK Spinous Process Plate · Orthopedic
Aug 2015 30d
Reform Pedicle Screw System
K150856 · NKB Thoracolumbosacral... · Orthopedic
Jul 2015 98d
Sure Lok Mini Posterior Cervical/Upper Thoracic System
K150851 · KWP Appliance, Fixation,... · Orthopedic
Jun 2015 65d
Reform Pedicle Screw System
K143248 · NKB Thoracolumbosacral... · Orthopedic
Dec 2014 37d
Interspinous Plate System
K142378 · PEK Spinous Process Plate · Orthopedic
Dec 2014 114d
SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM
K141397 · MNI Orthosis, Spinal Pedicle... · Orthopedic
Jun 2014 29d
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