Cleared Special

PathLoc SI Joint Fusion System

K240201 · L & K Biomed Co., Ltd. · Orthopedic
Feb 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K240201 is an FDA 510(k) clearance for the PathLoc SI Joint Fusion System, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on February 23, 2024, 29 days after receiving the submission on January 25, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K240201 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2024
Decision Date February 23, 2024
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OUR — Sacroiliac Joint Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion