510(k) K061144— DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT

Substantially Equivalent

DePuy Orthopaedics, Inc.

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code MBB
Advisory panel: Orthopedic
Date received: 2006-04-25
Decision date: 2006-06-08
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.