Cleared Traditional

ANTERIS Thoracolumbar Plate System

K260015 · SpineCraft · Orthopedic

Mar 2026

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K260015 is an FDA 510(k) clearance for the ANTERIS Thoracolumbar Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by SpineCraft (Westmont, US). The FDA issued a Cleared decision on March 4, 2026, 58 days after receiving the submission on January 5, 2026. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K260015 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 2026
Decision Date	March 04, 2026
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF