FIXATION SYSTEM— 510(k) K983318

Name: FDA 510(k) clearance K983318
Creator: U.S. Food and Drug Administration
Published: 1999-03-01

Substantially Equivalent

General Surgical Innovations

FDA 510(k) clearance K983318 for FIXATION SYSTEM, Substantially Equivalent on 1999-03-01. Applicant: General Surgical Innovations. Device class: 2.

Clearance details

Applicant: General Surgical Innovations
Product code: Code GDW
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 1998-09-21
Decision date: 1999-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.