K161166

Substantially Equivalent

StageOne Select Cement Spacer Molds for Temporary Hip Replacement

Applicant: Biomet, Inc.
Product code: MBB
Advisory panel: Orthopedic
Date received: 2016-04-26
Decision date: 2016-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Adverse events under product code MBB

product code MBB

Death: 27
Injury: 1,412
Malfunction: 551
Total: 1,990

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.