Cleared Traditional

Annex? 2 Adjacent Level System

K251131 · Spine Wave, Inc. · Orthopedic

Jun 2025

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K251131 is an FDA 510(k) clearance for the Annex? 2 Adjacent Level System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on June 6, 2025, 56 days after receiving the submission on April 11, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K251131 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 2025
Decision Date	June 06, 2025
Days to Decision	56 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.