POROCOAT MARK IV ELBOW— 510(k) K823473

Name: FDA 510(k) clearance K823473
Creator: U.S. Food and Drug Administration
Published: 1983-01-20

Substantially Equivalent

Depuy, Inc.

FDA 510(k) clearance K823473 for POROCOAT MARK IV ELBOW, Substantially Equivalent on 1983-01-20. Applicant: Depuy, Inc.. Device class: 2.

Clearance details

Applicant: Depuy, Inc.
Product code: Code JDB
Device class: Class 2
Regulation: 21 CFR 888.3160
Advisory panel: Orthopedic
Date received: 1982-11-22
Decision date: 1983-01-20
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.