Cleared Traditional

KONG-TL VBR System, KONG-C VBR System

K200235 · Icotec AG · Orthopedic
May 2020
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K200235 is an FDA 510(k) clearance for the KONG-TL VBR System, KONG-C VBR System, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Icotec AG (Altstaetten, CH). The FDA issued a Cleared decision on May 29, 2020, 120 days after receiving the submission on January 30, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K200235 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2020
Decision Date May 29, 2020
Days to Decision 120 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQP — Spinal Vertebral Body Replacement Device
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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