510(k) K915596— BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD

Substantially Equivalent for Some Indications

Biomet, Inc.

Clearance details

Applicant: Biomet, Inc.
Product code: Code KWT
Advisory panel: Orthopedic
Date received: 1991-12-13
Decision date: 1992-03-11
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Warsaw, IN, US

Adverse events under product code KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

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.