PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#— 510(k) K093719

Name: FDA 510(k) clearance K093719
Creator: U.S. Food and Drug Administration
Published: 2010-03-01

Substantially Equivalent

Osteogenics Biomedical, Inc.

FDA 510(k) clearance K093719 for PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#, Substantially Equivalent on 2010-03-01. Applicant: Osteogenics Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Osteogenics Biomedical, Inc.
Product code: Code DZL
Device class: Class 2
Regulation: 21 CFR 872.4880
Advisory panel: Dental
Date received: 2009-12-02
Decision date: 2010-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lubbock, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DZL

product code DZL

Injury: 168
Total: 168

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.