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FDA 510(k)

Dakota LP System

K-Number: K250769 · 2025-11-24

ApplicantPrecision Spine, Inc.
Decision Date2025-11-24
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dakota LP System is a medical device manufactured by Precision Spine, Inc.. It received FDA 510(k) clearance on 2025-11-24 under approval number K250769. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dakota LP System?

Dakota LP System is a medical device that received FDA 510(k) clearance on 2025-11-24. It is manufactured by Precision Spine, Inc.. The 510(k) number is K250769.

When was Dakota LP System approved by the FDA?

Dakota LP System received FDA 510(k) clearance on 2025-11-24, under approval number K250769.

What company makes Dakota LP System?

Dakota LP System is manufactured by Precision Spine, Inc..

What is the FDA product code for Dakota LP System?

The FDA product code for Dakota LP System is ODP.

Other Devices by Precision Spine, Inc.

K161809ShurFit CpTi-HA ACIF Interbody Fusion System K162211AccuFit Lateral Plate System K162300Reform® POCT System K160568Precision Spine Interspinous Plate System K173130Reform® Midline Cortical Screw System K171657ShurFit 2C Lumbar Interbody Fusion System

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Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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