BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW— 510(k) K982398

Name: FDA 510(k) clearance K982398
Creator: U.S. Food and Drug Administration
Published: 1998-08-11

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K982398 for BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW, Substantially Equivalent on 1998-08-11. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code JDC
Device class: Class 2
Regulation: 21 CFR 888.3150
Advisory panel: Orthopedic
Date received: 1998-07-10
Decision date: 1998-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JDC

product code JDC

Injury: 1,050
Total: 1,050

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.