Precision Spine, Inc. - FDA 510(k) Cleared Devices
24
Total
24
Cleared
0
Denied
FDA 510(k) cleared devices by Precision Spine, Inc. Orthopedic ✕
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
Cleared
Aug 11, 2017
ShurFit 2C Lumbar Interbody Fusion System
Orthopedic
67d
Cleared
Dec 06, 2016
ShurFit CpTi-HA ACIF Interbody Fusion System
Orthopedic
158d
Cleared
Nov 28, 2016
AccuFit Lateral Plate System
Orthopedic
112d
Cleared
Nov 22, 2016
Reform® POCT System
Orthopedic
98d
Cleared
May 04, 2016
Precision Spine Interspinous Plate System
Orthopedic
65d
Cleared
Aug 21, 2015
Reform Pedicle Screw System
Orthopedic
85d
Cleared
Aug 07, 2015
Precision Spine Interspinous Plate System
Orthopedic
30d
Cleared
Jul 07, 2015
Reform Pedicle Screw System
Orthopedic
98d
Cleared
Jun 04, 2015
Sure Lok Mini Posterior Cervical/Upper Thoracic System
Orthopedic
65d
Cleared
Dec 19, 2014
Reform Pedicle Screw System
Orthopedic
37d
Cleared
Dec 18, 2014
Interspinous Plate System
Orthopedic
114d
Cleared
Jun 26, 2014
SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM
Orthopedic
29d