Cleared Special

PathLoc SI Joint Fusion System

K231841 · L & K Biomed Co., Ltd. · Orthopedic
Jul 2023
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K231841 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 July 14, 2023, 22 days after receiving the submission on June 22, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K231841 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2023
Decision Date July 14, 2023
Days to Decision 22 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