meddevicedb.com FDA Device Reference

PathLoc-L MIS Spinal System

K161766 Class II Traditional
Decision Date
2016-08-22
Sponsor / Applicant
L&K BIOMED Co., Ltd.

Technical Specification

510(k) Submission ID K161766
Product Code NKB
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3070
Decision Date 2016-08-22
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

PathLoc-L MIS Spinal System received FDA 510(k) clearance under submission number K161766, sponsored by L&K BIOMED Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2016-08-22.

Classification & Regulation

This clearance is catalogued under FDA product code NKB and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.