PRO FIXATION SYSTEM— 510(k) K110538

Substantially Equivalent

Synovis Orthopedic & Woundcare

FDA 510(k) clearance K110538 for PRO FIXATION SYSTEM, Substantially Equivalent on 2011-07-12. Applicant: Synovis Orthopedic & Woundcare.

Clearance details

Applicant: Synovis Orthopedic & Woundcare
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2011-02-25
Decision date: 2011-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.