Cleared Special

CastleLoc Spinal Fixation System

K162801 · L & K Biomed Co., Ltd. · Orthopedic
Nov 2016
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K162801 is an FDA 510(k) clearance for the CastleLoc Spinal Fixation System, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on November 3, 2016, 29 days after receiving the submission on October 5, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K162801 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 2016
Decision Date November 03, 2016
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MNH — Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3070