Medical Device Manufacturer · US , Pear , MS

Precision Spine, Inc. - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 2014

Recent clearances: Dakota LP System, Reform Pedicle Screw System, S-COMP Reform® POCT Navigation Instruments

24
Total
24
Cleared
0
Denied

Precision Spine, Inc. has 24 FDA 510(k) cleared orthopedic devices. Based in Pear, US.

Latest FDA clearance: Nov 2025. Active since 2014.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Empirical Testing Corp, Empirical Technologies and Empirical Consulting.

FDA 510(k) Regulatory Record - Precision Spine, Inc.

24 devices
1-24 of 24
Cleared Nov 24, 2025
Dakota LP System
K250769 · ODP
Orthopedic · 256d
Cleared Dec 17, 2024
Reform Pedicle Screw System
K242297 · NKB
Orthopedic · 137d
Cleared May 25, 2023
S-COMP Reform® POCT Navigation Instruments
K231229 · OLO
Orthopedic · 27d
Cleared Jul 14, 2022
E-GPS Navigated Instruments
K220862 · OLO
Orthopedic · 112d
Cleared Apr 01, 2022
Dakota ALIF System
K213118 · OVD
Orthopedic · 186d
Cleared Mar 16, 2022
AccuFit Lateral 2-Hole Plate
K220324 · KWQ
Orthopedic · 41d
Cleared Dec 08, 2021
ShurFit Lumbar Interbody System
K212075 · MAX
Orthopedic · 159d
Cleared Nov 04, 2021
Dakota ALIF Plate System
K212937 · KWQ
Orthopedic · 50d
Cleared Jan 12, 2021
NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
K203129 · OVE
Orthopedic · 85d
Cleared Sep 27, 2019
Precision Spine Navigation Instrumentation
K181606 · OLO
Orthopedic · 465d
Cleared Apr 11, 2018
Reform® POCT System
K172495 · NKG
Orthopedic · 236d
Cleared Dec 19, 2017
Reform® Midline Cortical Screw System
K173130 · NKB
Orthopedic · 81d
Cleared Aug 11, 2017
ShurFit 2C Lumbar Interbody Fusion System
K171657 · MAX
Orthopedic · 67d
Cleared Dec 06, 2016
ShurFit CpTi-HA ACIF Interbody Fusion System
K161809 · ODP
Orthopedic · 158d
Cleared Nov 28, 2016
AccuFit Lateral Plate System
K162211 · KWQ
Orthopedic · 112d
Cleared Nov 22, 2016
Reform® POCT System
K162300 · NKG
Orthopedic · 98d
Cleared May 04, 2016
Precision Spine Interspinous Plate System
K160568 · PEK
Orthopedic · 65d
Cleared Aug 21, 2015
Reform Pedicle Screw System
K151422 · NKB
Orthopedic · 85d
Cleared Aug 07, 2015
Precision Spine Interspinous Plate System
K151863 · PEK
Orthopedic · 30d
Cleared Jul 07, 2015
Reform Pedicle Screw System
K150856 · NKB
Orthopedic · 98d
Cleared Jun 04, 2015
Sure Lok Mini Posterior Cervical/Upper Thoracic System
K150851 · KWP
Orthopedic · 65d
Cleared Dec 19, 2014
Reform Pedicle Screw System
K143248 · NKB
Orthopedic · 37d
Cleared Dec 18, 2014
Interspinous Plate System
K142378 · PEK
Orthopedic · 114d
Cleared Jun 26, 2014
SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM
K141397 · MNI
Orthopedic · 29d
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