DYNASTY BIOFOAM SHELL— 510(k) K122382

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K122382 for DYNASTY BIOFOAM SHELL, Substantially Equivalent on 2012-10-22. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code MBL
Advisory panel: Orthopedic
Date received: 2012-08-06
Decision date: 2012-10-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBL

product code MBL

Injury: 439
Total: 439

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.