Cleared Traditional

Kleiner KG2 System

K211474 · BAAT Medical Products B.V. · Orthopedic

Sep 2021

Decision

125d

Days

Class 2

Risk

About This 510(k) Submission

K211474 is an FDA 510(k) clearance for the Kleiner KG2 System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by BAAT Medical Products B.V. (Hengelo, NL). The FDA issued a Cleared decision on September 14, 2021, 125 days after receiving the submission on May 12, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K211474 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 2021
Decision Date	September 14, 2021
Days to Decision	125 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.