LORENZ SELF-DRILLING IMF SCREW— 510(k) K040983

Name: FDA 510(k) clearance K040983
Creator: U.S. Food and Drug Administration
Published: 2004-05-05

Substantially Equivalent

Walter Lorenz Surgical, Inc.

FDA 510(k) clearance K040983 for LORENZ SELF-DRILLING IMF SCREW, Substantially Equivalent on 2004-05-05. Applicant: Walter Lorenz Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Walter Lorenz Surgical, Inc.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2004-04-15
Decision date: 2004-05-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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K063386 — LORENZ ORTHODONTIC ANCHORAGE SYSTEM2007-02-09
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K063506 — LORENZ STERNAL CLOSURE SYSTEM2006-12-18
K062842 — TWIST DRILL2006-12-04
K061384 — LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM2006-06-06

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

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.