Cleared Special

MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM

K020522 · Depuyacromed · Orthopedic
Mar 2002
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K020522 is an FDA 510(k) clearance for the MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on March 21, 2002, 30 days after receiving the submission on February 19, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K020522 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2002
Decision Date March 21, 2002
Days to Decision 30 days
Submission Type Special
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

Similar Devices — MQP Spinal Vertebral Body Replacement Device

All 276
VyBrate? VBR System
K253158 · Vy Spine, LLC · Jan 2026
Vertiwedge? Intraosseous System
K241468 · Foundation Surgical Group, Inc. · Nov 2024
KONG?-TL VBR System and KONG? C VBR System
K232790 · Icotec AG · Apr 2024
DOMINION Expandable Corpectomy System
K233359 · Astura Medical · Mar 2024
VerteLoc Spinal System
K231134 · Signature Orthopaedics Pty, Ltd. · Feb 2024
Ascend VBR System, Ascend NanoTec VBR System
K232173 · Alphatec Spine, Inc. · Oct 2023