# Precision Spine, Inc.

- Location (FDA's records): Pear, MS
- FDA decisions: 26 (2014–2025): 26 510(k) clearances
- Names in FDA's records: Precision Spine, Inc. (24); Precision Spine (2)
- Product codes: NKB (6), KWQ (4), PEK (3), OLO (3), MAX (2), ODP (2), NKG (2), KWP (1), MNI (1), OVD (1), OVE (1)
- 510(k) review time since 2016: median 103 days, against 89 for FDA's reviews in the same codes and years (8 of 19 faster)
- Predicates its devices cite: 113 (17 its own); citations of its devices by later devices: 36 (17 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Spinal USA: 35 (https://510kreport.com/company/spinal-usa)
- Medtronic Sofamor Danek USA, Inc.: 5 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Biomet Spine (Aka Ebi, LLC): 4 (https://510kreport.com/company/biomet-spine-aka-ebi)
- Stryker Corp.: 3 (https://510kreport.com/company/stryker)
- Synthes Spine: 3 (https://510kreport.com/company/synthes-spine)
- Depuy Spine, Inc.: 3 (https://510kreport.com/company/depuy-spine)
- Globus Medical, Inc.: 3 (https://510kreport.com/company/globus-medical)
- Nuvasive, Inc.: 2 (https://510kreport.com/company/nuvasive)

## Firms that cite its devices most
- Spineart: 3 (https://510kreport.com/company/spineart)
- Camber Spine Technologies: 2 (https://510kreport.com/company/camber-spine-technologies)
- DePuy Synthes: 1 (https://510kreport.com/company/depuy-synthes)
- Spinal Elements, Inc.: 1 (https://510kreport.com/company/spinal-elements)
- SI-BONE, Inc.: 1 (https://510kreport.com/company/si-bone)
- Promethean Restorative, LLC: 1 (https://510kreport.com/company/promethean-restorative)
- Spine Wave, Inc.: 1 (https://510kreport.com/company/spine-wave)
- Osseus Fusion Systems, LLC: 1 (https://510kreport.com/company/osseus-fusion-systems)

## Its most-cited devices
- K220862: E-GPS Navigated Instruments (2022), cited by 4
- K173130: Reform® Midline Cortical Screw System (2017), cited by 3
- K181606: Precision Spine Navigation Instrumentation (2019), cited by 3
- K143248: Reform Pedicle Screw System (2014), cited by 3
- K171657: ShurFit 2C Lumbar Interbody Fusion System (2017), cited by 3
- K150856: Reform Pedicle Screw System (2015), cited by 3

## Recent decisions
- K250769: Dakota LP System (Nov 24, 2025)
- K242297: Reform Pedicle Screw System (Dec 17, 2024)
- K231229: S-COMP Reform® POCT Navigation Instruments (May 25, 2023)
- K220862: E-GPS Navigated Instruments (Jul 14, 2022)
- K213118: Dakota ALIF System (Apr 1, 2022)
- K220324: AccuFit Lateral 2-Hole Plate (Mar 16, 2022)
- K212075: ShurFit Lumbar Interbody System (Dec 8, 2021)
- K212937: Dakota ALIF Plate System (Nov 4, 2021)

Source page: https://510kreport.com/company/precision-spine