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Vantage 3D PSI

3D SYSTEMS, INC. · Model Talus Cutting Guide · UDI-DI 00816847022804

OYK Prescription
7
510(k) clearances
11
Adverse events
1
Recalls
12
Facilities

Description

A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.

Recalls

DateFirmReason
2011-11-17Integra LifeSciences Corp.During 6/30/2010 to 8/17/2011 the firm received five (5) incident complaints of breakage of the threaded part of the compression guide which potentially occurred when: 1) a compre

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.