Cleared Traditional

Exceed? Biplanar Expandable Interbody System

K231275 · Spine Wave, Inc. · Orthopedic

Jul 2023

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K231275 is an FDA 510(k) clearance for the Exceed? Biplanar Expandable Interbody 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 July 25, 2023, 84 days after receiving the submission on May 2, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K231275 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2023
Decision Date	July 25, 2023
Days to Decision	84 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.