COBALT CHROME GEMINI— 510(k) K934909

Name: FDA 510(k) clearance K934909
Creator: U.S. Food and Drug Administration
Published: 1994-04-28

Substantially Equivalent

Depuy, Inc.

FDA 510(k) clearance K934909 for COBALT CHROME GEMINI, Substantially Equivalent on 1994-04-28. Applicant: Depuy, Inc.. Device class: 2.

Clearance details

Applicant: Depuy, Inc.
Product code: Code LWJ
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1993-10-14
Decision date: 1994-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.