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Precision Spine, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
26
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250769Dakota LP SystemNovember 24, 2025
K242297Reform Pedicle Screw SystemDecember 17, 2024
K231229S-COMP Reform® POCT Navigation InstrumentsMay 25, 2023
K220862E-GPS Navigated InstrumentsJuly 14, 2022
K213118Dakota ALIF SystemApril 1, 2022
K220324AccuFit Lateral 2-Hole PlateMarch 16, 2022
K212075ShurFit Lumbar Interbody SystemDecember 8, 2021
K212937Dakota ALIF Plate SystemNovember 4, 2021
K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemJanuary 12, 2021
K200303Reform Pedicle Screw SystemMay 19, 2020
K192494NexGen Anterior Cervical Plate SystemOctober 29, 2019
K181606Precision Spine Navigation InstrumentationSeptember 27, 2019
K172495Reform® POCT SystemApril 11, 2018
K173130Reform® Midline Cortical Screw SystemDecember 19, 2017
K171657ShurFit 2C Lumbar Interbody Fusion SystemAugust 11, 2017
K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemDecember 6, 2016
K162211AccuFit Lateral Plate SystemNovember 28, 2016
K162300Reform® POCT SystemNovember 22, 2016
K160568Precision Spine Interspinous Plate SystemMay 4, 2016
K151422Reform Pedicle Screw SystemAugust 21, 2015