Cleared Traditional

PathLoc Lumbar Interbody Fusion Cage System

K213441 · L & K Biomed Co., Ltd. · Orthopedic

Mar 2022

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K213441 is an FDA 510(k) clearance for the PathLoc Lumbar Interbody Fusion Cage System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on March 9, 2022, 135 days after receiving the submission on October 25, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K213441 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 25, 2021
Decision Date	March 09, 2022
Days to Decision	135 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.