WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION— 510(k) K902538

Name: FDA 510(k) clearance K902538
Creator: U.S. Food and Drug Administration
Published: 1990-07-06

Substantially Equivalent for Some Indications

Dow Corning Wright

FDA 510(k) clearance K902538 for WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION, Substantially Equivalent for Some Indications on 1990-07-06. Applicant: Dow Corning Wright. Device class: 2.

Clearance details

Applicant: Dow Corning Wright
Product code: Code HRY
Device class: Class 2
Regulation: 21 CFR 888.3530
Advisory panel: Orthopedic
Date received: 1990-06-06
Decision date: 1990-07-06
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

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.