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Precision Spine, Inc.

24 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Dakota LP System (K250769)Precision Spine, Inc.2025-11-24
Reform Pedicle Screw System (K242297)Precision Spine, Inc.2024-12-17
S-COMP Reform® POCT Navigation Instruments (K231229)Precision Spine, Inc.2023-05-25
E-GPS Navigated Instruments (K220862)Precision Spine, Inc.2022-07-14
Dakota ALIF System (K213118)Precision Spine, Inc.2022-04-01
AccuFit Lateral 2-Hole Plate (K220324)Precision Spine, Inc.2022-03-16
ShurFit Lumbar Interbody System (K212075)Precision Spine, Inc.2021-12-08
Dakota ALIF Plate System (K212937)Precision Spine, Inc.2021-11-04
NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System (K203129)Precision Spine, Inc.2021-01-12
Precision Spine Navigation Instrumentation (K181606)Precision Spine, Inc.2019-09-27
Reform® POCT System (K172495)Precision Spine, Inc.2018-04-11
Reform® Midline Cortical Screw System (K173130)Precision Spine, Inc.2017-12-19
ShurFit 2C Lumbar Interbody Fusion System (K171657)Precision Spine, Inc.2017-08-11
ShurFit CpTi-HA ACIF Interbody Fusion System (K161809)Precision Spine, Inc.2016-12-06
AccuFit Lateral Plate System (K162211)Precision Spine, Inc.2016-11-28
Reform® POCT System (K162300)Precision Spine, Inc.2016-11-22
Precision Spine Interspinous Plate System (K160568)Precision Spine, Inc.2016-05-04
Reform Pedicle Screw System (K151422)Precision Spine, Inc.2015-08-21
Precision Spine Interspinous Plate System (K151863)Precision Spine, Inc.2015-08-07
Reform Pedicle Screw System (K150856)Precision Spine, Inc.2015-07-07
Sure Lok Mini Posterior Cervical/Upper Thoracic System (K150851)Precision Spine, Inc.2015-06-04
Reform Pedicle Screw System (K143248)Precision Spine, Inc.2014-12-19
Interspinous Plate System (K142378)Precision Spine, Inc.2014-12-18
SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM (K141397)Precision Spine, Inc.2014-06-26

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Every clearance here is in the API, with alerts when new ones post.