Precision Spine, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Precision Spine, Inc. - FDA 510(k) Cleared Devices
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
Cleared
Nov 24, 2025
Dakota LP System
Orthopedic
256d
Cleared
Dec 17, 2024
Reform Pedicle Screw System
Orthopedic
137d
Cleared
May 25, 2023
S-COMP Reform® POCT Navigation Instruments
Orthopedic
27d
Cleared
Jul 14, 2022
E-GPS Navigated Instruments
Orthopedic
112d
Cleared
Apr 01, 2022
Dakota ALIF System
Orthopedic
186d
Cleared
Mar 16, 2022
AccuFit Lateral 2-Hole Plate
Orthopedic
41d
Cleared
Dec 08, 2021
ShurFit Lumbar Interbody System
Orthopedic
159d
Cleared
Nov 04, 2021
Dakota ALIF Plate System
Orthopedic
50d
Cleared
Jan 12, 2021
NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
Orthopedic
85d
Cleared
Sep 27, 2019
Precision Spine Navigation Instrumentation
Orthopedic
465d
Cleared
Apr 11, 2018
Reform® POCT System
Orthopedic
236d
Cleared
Dec 19, 2017
Reform® Midline Cortical Screw System
Orthopedic
81d