Cleared Traditional

KONG?-TL VBR System and KONG? C VBR System

K232790 · Icotec AG · Orthopedic
Apr 2024
Decision
206d
Days
Class 2
Risk

About This 510(k) Submission

K232790 is an FDA 510(k) clearance for the KONG?-TL VBR System and KONG? C VBR System, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Icotec AG (9450 Altstaetten (Sg), CH). The FDA issued a Cleared decision on April 4, 2024, 206 days after receiving the submission on September 11, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K232790 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2023
Decision Date April 04, 2024
Days to Decision 206 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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