Cleared Traditional

Universal Spinal System

K252729 · Double Medical Technology, Inc. · Orthopedic

Nov 2025

Decision

82d

Days

Class 2

Risk

About This 510(k) Submission

K252729 is an FDA 510(k) clearance for the Universal Spinal System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Double Medical Technology, Inc. (Xiamen, CN). The FDA issued a Cleared decision on November 18, 2025, 82 days after receiving the submission on August 28, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K252729 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2025
Decision Date	November 18, 2025
Days to Decision	82 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.