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FDA 510(k)

COBALT CHROME GEMINI

K-Number: K934909 · 1994-04-28

ApplicantDepuy, Inc.
Decision Date1994-04-28
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COBALT CHROME GEMINI is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1994-04-28 under 510(k) number K934909. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBALT CHROME GEMINI?

COBALT CHROME GEMINI is a medical device that received FDA 510(k) clearance on 1994-04-28. The listed applicant is Depuy, Inc.. The 510(k) number is K934909.

When did COBALT CHROME GEMINI receive FDA 510(k) clearance?

COBALT CHROME GEMINI received FDA 510(k) clearance on 1994-04-28, under 510(k) number K934909.

Who is the listed applicant for COBALT CHROME GEMINI?

The FDA 510(k) record lists Depuy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBALT CHROME GEMINI?

The FDA product code for COBALT CHROME GEMINI is LWJ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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