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Unity Lx Anterolateral Lumbar Plate Fixation System

by Blackstone Medical, Inc. 510(k)

Active United States

510(k) K061229

Overview

The UNITY LX Anterior Lateral Lumbar Plate Fixation System is a minimally invasive, image-guided orthopedic solution designed to provide stable and secure fixation of the lumbar spine. This system offers improved accuracy, reduced recovery time, and enhanced patient outcomes compared to traditional methods.

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061229 Date24 Jul 2006ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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