STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM— 510(k) K041651

Name: FDA 510(k) clearance K041651
Creator: U.S. Food and Drug Administration
Published: 2004-09-30

Substantially Equivalent

Stryker Leibinger

FDA 510(k) clearance K041651 for STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM, Substantially Equivalent on 2004-09-30. Applicant: Stryker Leibinger. Device class: 2.

Clearance details

Applicant: Stryker Leibinger
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2004-06-17
Decision date: 2004-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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K260463 — ZEROS Dental Implant System2026-08-19
K251188 — UNIQA® Dental Implants System2026-06-25
K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

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K040022 — STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM2004-03-12
K022579 — STRYKER NAVIGATION SYSTEM-KNEE MODULE2003-06-02
K023449 — NON-INVASIVE PATIENT FIXATION SYSTEM2003-01-13

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.