CONFIDENCE FENESTRATED INTRODUCER NEEDLE— 510(k) K063067

Name: FDA 510(k) clearance K063067
Creator: U.S. Food and Drug Administration
Published: 2006-11-03

Substantially Equivalent

Disc-O-Tech Medical Technologies, Ltd.

FDA 510(k) clearance K063067 for CONFIDENCE FENESTRATED INTRODUCER NEEDLE, Substantially Equivalent on 2006-11-03. Applicant: Disc-O-Tech Medical Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Disc-O-Tech Medical Technologies, Ltd.
Product code: Code NDN
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2006-10-06
Decision date: 2006-11-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K071679 — METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS2007-12-17
K062424 — CONFIDENCE EX HIGH VISCOSITY BONE CEMENT2006-09-14
K060300 — CONFIDENCE HIGH VISCOSITY BONE CEMENT2006-06-21
K040612 — SKY BONE EXPANDER SYSTEM (SKY SYSTEM)2004-06-17

Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.