Surgimatix Absorbable Fixation System— 510(k) K201934

Substantially Equivalent

Surgimatix, Inc.

FDA 510(k) clearance K201934 for Surgimatix Absorbable Fixation System, Substantially Equivalent on 2021-10-01. Applicant: Surgimatix, Inc..

Clearance details

Applicant: Surgimatix, Inc.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2020-07-13
Decision date: 2021-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elk Grove Village, IL, US

Download summary PDF View on FDA.gov ↗

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.