MOLDED POLYSULFONE TRIAL PROSTHESIS— 510(k) K811205

Substantially Equivalent

Shannon Group

FDA 510(k) clearance K811205 for MOLDED POLYSULFONE TRIAL PROSTHESIS, Substantially Equivalent on 1981-05-21. Applicant: Shannon Group.

Clearance details

Applicant: Shannon Group
Product code: Code HWT
Advisory panel: Orthopedic
Date received: 1981-05-01
Decision date: 1981-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWT

product code HWT

Injury: 218
Malfunction: 12,907
Total: 13,125

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.