Precision Spine, Inc.
Pearl, MS, US
Precision Spine, Inc. appears in FDA device records in Pearl, MS. FDA records list 26 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 26 510(k) clearances for Precision Spine, Inc. between 2014 and 2025. The busiest year on record is 2015, with 4. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 3 |
| 2015 | 4 |
| 2016 | 4 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250769 | Dakota LP System | ODP | Substantially Equivalent | |
| K242297 | Reform Pedicle Screw System | NKB | Substantially Equivalent | |
| K231229 | S-COMP Reform® POCT Navigation Instruments | OLO | Substantially Equivalent | |
| K220862 | E-GPS Navigated Instruments | OLO | Substantially Equivalent | |
| K213118 | Dakota ALIF System | OVD | Substantially Equivalent | |
| K220324 | AccuFit Lateral 2-Hole Plate | KWQ | Substantially Equivalent | |
| K212075 | ShurFit Lumbar Interbody System | MAX | Substantially Equivalent | |
| K212937 | Dakota ALIF Plate System | KWQ | Substantially Equivalent | |
| K203129 | NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System | OVE | Substantially Equivalent | |
| K200303 | Reform Pedicle Screw System | NKB | Substantially Equivalent | |
| K192494 | NexGen Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K181606 | Precision Spine Navigation Instrumentation | OLO | Substantially Equivalent | |
| K172495 | Reform® POCT System | NKG | Substantially Equivalent | |
| K173130 | Reform® Midline Cortical Screw System | NKB | Substantially Equivalent | |
| K171657 | ShurFit 2C Lumbar Interbody Fusion System | MAX | Substantially Equivalent | |
| K161809 | ShurFit CpTi-HA ACIF Interbody Fusion System | ODP | Substantially Equivalent | |
| K162211 | AccuFit Lateral Plate System | KWQ | Substantially Equivalent | |
| K162300 | Reform® POCT System | NKG | Substantially Equivalent | |
| K160568 | Precision Spine Interspinous Plate System | PEK | Substantially Equivalent | |
| K151422 | Reform Pedicle Screw System | NKB | Substantially Equivalent | |
| K151863 | Precision Spine Interspinous Plate System | PEK | Substantially Equivalent | |
| K150856 | Reform Pedicle Screw System | NKB | Substantially Equivalent | |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic System | KWP | Substantially Equivalent | |
| K143248 | Reform Pedicle Screw System | NKB | Substantially Equivalent | |
| K142378 | Interspinous Plate System | PEK | Substantially Equivalent | |
| K141397 | SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005739886 | 3005739886 | Precision Spine, Inc. | 2050 Executive Dr, Pearl, MS 39208 US | 2026 | and 38 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- HXWBender
- HTWBit, Drill
- PMLBone Cement, Posterior Screw Augmentation
- KTZCaliper
- FZOChisel, Surgical, Manual
- HTFCurette
- FZTCutter, Surgical
- HTEElevator
- HWBExtractor
- HTDForceps
- HXEFork
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- HWAImpactor
- HXPInstrument, Bending Or Contouring
- HWNInstrument, Compression
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- HXLMallet
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HWMOsteotome
- HXIPasser, Wire, Orthopedic
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- NKGPosterior Cervical Screw System
- HXBProbe
- JDKProsthesis, Hip, Cement Restrictor
- LRYPunch, Surgical
- HTRRasp
- GADRetractor
- HTXRongeur
- HXXScrewdriver
- PEKSpinous Process Plate
- HWDStarter, Bone Screw
- MRWSystem, Facet Screw Spinal Device
- HXGTamp
- HWXTap, Bone
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- HXCWrench
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain