Cleared Traditional

PathLoc Lumbar Plate System

K251940 · L & K Biomed Co., Ltd. · Orthopedic
Mar 2026
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K251940 is an FDA 510(k) clearance for the PathLoc Lumbar Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on March 3, 2026, 252 days after receiving the submission on June 24, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K251940 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2025
Decision Date March 03, 2026
Days to Decision 252 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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