ADVANCE TIBIAL COMPONENT— 510(k) K960617

Name: FDA 510(k) clearance K960617
Creator: U.S. Food and Drug Administration
Published: 1996-05-08

Substantially Equivalent for Some Indications

Wrightmedicaltechnologyinc

FDA 510(k) clearance K960617 for ADVANCE TIBIAL COMPONENT, Substantially Equivalent for Some Indications on 1996-05-08. Applicant: Wrightmedicaltechnologyinc. Device class: 2.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code HRY
Device class: Class 2
Regulation: 21 CFR 888.3530
Advisory panel: Orthopedic
Date received: 1996-02-13
Decision date: 1996-05-08
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.