Precision Spine, Inc.
Medical device manufacturer in Pear, MS.
26510(k) clearances
0PMA approvals
0recalls
Device types
- NKB Thoracolumbosacral Pedicle Screw System 6
- KWQ Appliance, Fixation, Spinal Intervertebral… 4
- PEK Spinous Process Plate 3
- OLO Orthopedic Stereotaxic Instrument 3
- NKG Posterior Cervical Screw System 2
- ODP Intervertebral Fusion Device With Bone… 2
- MAX Intervertebral Fusion Device With Bone… 2
- MNI Orthosis, Spinal Pedicle Fixation 1
- KWP Appliance, Fixation, Spinal Interlaminal 1
- OVE Intervertebral Fusion Device With… 1
- OVD Intervertebral Fusion Device With… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K250769 | Dakota LP SystemODP · Traditional | 11/24/2025SE |
| K242297 | Reform Pedicle Screw SystemNKB · Traditional | 12/17/2024SE |
| K231229 | S-COMP Reform® POCT Navigation InstrumentsOLO · Special | 05/25/2023SE |
| K220862 | E-GPS Navigated InstrumentsOLO · Traditional | 07/14/2022SE |
| K213118 | Dakota ALIF SystemOVD · Traditional | 04/01/2022SE |
| K220324 | AccuFit Lateral 2-Hole PlateKWQ · Traditional | 03/16/2022SE |
| K212075 | ShurFit Lumbar Interbody SystemMAX · Traditional | 12/08/2021SE |
| K212937 | Dakota ALIF Plate SystemKWQ · Traditional | 11/04/2021SE |
| K203129 | NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemOVE · Traditional | 01/12/2021SE |
| K200303 | Reform Pedicle Screw SystemNKB · Traditional | 05/19/2020SE |
| K192494 | NexGen Anterior Cervical Plate SystemKWQ · Traditional | 10/29/2019SE |
| K181606 | Precision Spine Navigation InstrumentationOLO · Traditional | 09/27/2019SE |
| K172495 | Reform® POCT SystemNKG · Traditional | 04/11/2018SE |
| K173130 | Reform® Midline Cortical Screw SystemNKB · Traditional | 12/19/2017SE |
| K171657 | ShurFit 2C Lumbar Interbody Fusion SystemMAX · Traditional | 08/11/2017SE |
| K161809 | ShurFit CpTi-HA ACIF Interbody Fusion SystemODP · Traditional | 12/06/2016SE |
| K162211 | AccuFit Lateral Plate SystemKWQ · Traditional | 11/28/2016SE |
| K162300 | Reform® POCT SystemNKG · Traditional | 11/22/2016SE |
| K160568 | Precision Spine Interspinous Plate SystemPEK · Traditional | 05/04/2016SE |
| K151422 | Reform Pedicle Screw SystemNKB · Traditional | 08/21/2015SE |
| K151863 | Precision Spine Interspinous Plate SystemPEK · Special | 08/07/2015SE |
| K150856 | Reform Pedicle Screw SystemNKB · Special | 07/07/2015SE |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Special | 06/04/2015SE |
| K143248 | Reform Pedicle Screw SystemNKB · Traditional | 12/19/2014SE |
| K142378 | Interspinous Plate SystemPEK · Traditional | 12/18/2014SE |
| K141397 | Sure-Lok C Extended Tab Pedicle Screw SystemMNI · Special | 06/26/2014SE |