HYDROXYLAPATITE INFINITY(R)— 510(k) K920969

Substantially Equivalent

Dow Corning Wright

FDA 510(k) clearance K920969 for HYDROXYLAPATITE INFINITY(R), Substantially Equivalent on 1993-05-05. Applicant: Dow Corning Wright.

Clearance details

Applicant: Dow Corning Wright
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 1992-03-02
Decision date: 1993-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

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Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

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.