Cleared Traditional

Dakota LP System

K250769 · Precision Spine, Inc. · Orthopedic

Nov 2025

Decision

256d

Days

Class 2

Risk

About This 510(k) Submission

K250769 is an FDA 510(k) clearance for the Dakota LP System, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Precision Spine, Inc. (Pear, US). The FDA issued a Cleared decision on November 24, 2025, 256 days after receiving the submission on March 13, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K250769 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2025
Decision Date	November 24, 2025
Days to Decision	256 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	ODP — Intervertebral Fusion Device With Bone Graft, Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.