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FDA 510(k)

FOCUS COBALT CHROMIUM TOTAL HIP

K-Number: K904351 · 1990-10-17

ApplicantDepuy, Inc.
Decision Date1990-10-17
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

FOCUS COBALT CHROMIUM TOTAL HIP is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1990-10-17 under 510(k) number K904351. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the FOCUS COBALT CHROMIUM TOTAL HIP?

FOCUS COBALT CHROMIUM TOTAL HIP is a medical device that received FDA 510(k) clearance on 1990-10-17. The listed applicant is Depuy, Inc.. The 510(k) number is K904351.

When did FOCUS COBALT CHROMIUM TOTAL HIP receive FDA 510(k) clearance?

FOCUS COBALT CHROMIUM TOTAL HIP received FDA 510(k) clearance on 1990-10-17, under 510(k) number K904351.

Who is the listed applicant for FOCUS COBALT CHROMIUM TOTAL HIP?

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 FOCUS COBALT CHROMIUM TOTAL HIP?

The FDA product code for FOCUS COBALT CHROMIUM TOTAL HIP is JDI.

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Other records listing Depuy, Inc. as applicant

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Related Devices (Code: JDI)

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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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