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Precision Spine, Inc.

FDA 510(k) & PMA Approved Devices — 17 products

Total Devices17
Categories9
Latest FDA decision2025-11-24
TypeNumberDevice NameCodeDateActions
510(k) K250769 Dakota LP SystemODP2025-11-24 View
510(k) K242297 Reform Pedicle Screw SystemNKB2024-12-17 View
510(k) K231229 S-COMP Reform® POCT Navigation InstrumentsOLO2023-05-25 View
510(k) K220862 E-GPS Navigated InstrumentsOLO2022-07-14 View
510(k) K213118 Dakota ALIF SystemOVD2022-04-01 View
510(k) K220324 AccuFit Lateral 2-Hole PlateKWQ2022-03-16 View
510(k) K212075 ShurFit Lumbar Interbody SystemMAX2021-12-08 View
510(k) K212937 Dakota ALIF Plate SystemKWQ2021-11-04 View
510(k) K203129 NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemOVE2021-01-12 View
510(k) K181606 Precision Spine Navigation InstrumentationOLO2019-09-27 View
510(k) K172495 Reform® POCT SystemNKG2018-04-11 View
510(k) K173130 Reform® Midline Cortical Screw SystemNKB2017-12-19 View
510(k) K171657 ShurFit 2C Lumbar Interbody Fusion SystemMAX2017-08-11 View
510(k) K161809 ShurFit CpTi-HA ACIF Interbody Fusion SystemODP2016-12-06 View
510(k) K162211 AccuFit Lateral Plate SystemKWQ2016-11-28 View
510(k) K162300 Reform® POCT SystemNKG2016-11-22 View
510(k) K160568 Precision Spine Interspinous Plate SystemPEK2016-05-04 View
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