K240201

PathLoc SI Joint Fusion System

510(k) number
K240201
Device name
PathLoc SI Joint Fusion System
Applicant
L&K BIOMED Co., Ltd. KR
Product code
OUR — Sacroiliac Joint Fixation
Decision date
2024-02-23
Date received
2024-01-25
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain

Also available from FDA: K240201.pdf

Official FDA record: K240201
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.