Cleared Traditional

Testa TP Pivoting Spacer System

K243816 · Spine Wave, Inc. · Orthopedic

Jun 2025

Decision

197d

Days

Class 2

Risk

About This 510(k) Submission

K243816 is an FDA 510(k) clearance for the Testa TP Pivoting Spacer System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on June 27, 2025, 197 days after receiving the submission on December 12, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K243816 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 12, 2024
Decision Date	June 27, 2025
Days to Decision	197 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

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