SUFACE REPLACEMENT ELBOW— 510(k) K820957

Name: FDA 510(k) clearance K820957
Creator: U.S. Food and Drug Administration
Published: 1982-07-02

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K820957 for SUFACE REPLACEMENT ELBOW, Substantially Equivalent on 1982-07-02. Applicant: Howmedica Corp.. Device class: 2.

Clearance details

Applicant: Howmedica Corp.
Product code: Code JDB
Device class: Class 2
Regulation: 21 CFR 888.3160
Advisory panel: Orthopedic
Date received: 1982-04-06
Decision date: 1982-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JDB

product code JDB

Injury: 352
Total: 352

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.