Osseointegrated Fixtures— 510(k) K161548

Name: FDA 510(k) clearance K161548
Creator: U.S. Food and Drug Administration
Published: 2016-12-01

Substantially Equivalent

Southern Implants (Pty), Ltd.

FDA 510(k) clearance K161548 for Osseointegrated Fixtures, Substantially Equivalent on 2016-12-01. Applicant: Southern Implants (Pty), Ltd.. Device class: 2.

Clearance details

Applicant: Southern Implants (Pty), Ltd.
Product code: Code FZE
Device class: Class 2
Regulation: 21 CFR 878.3680
Advisory panel: General, Plastic Surgery
Date received: 2016-06-03
Decision date: 2016-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irene, ZA

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FZE

product code FZE

Injury: 138
Total: 138

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.