510(k) K043100— BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS

Substantially Equivalent

Biomet, Inc.

Clearance details

Applicant: Biomet, Inc.
Product code: Code MBF
Advisory panel: Orthopedic
Date received: 2004-11-09
Decision date: 2005-02-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Adverse events under product code MBF

product code MBF

Injury: 597
Total: 597

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.