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FDA 510(k)

DISTAL CENTRALIZER, EXETER II HIP SYSTEM

K-Number: K974054 · 1997-12-23

ApplicantHowmedica, Inc.
Decision Date1997-12-23
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DISTAL CENTRALIZER, EXETER II HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica, Inc.. It received FDA 510(k) clearance on 1997-12-23 under 510(k) number K974054. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISTAL CENTRALIZER, EXETER II HIP SYSTEM?

DISTAL CENTRALIZER, EXETER II HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1997-12-23. The listed applicant is Howmedica, Inc.. The 510(k) number is K974054.

When did DISTAL CENTRALIZER, EXETER II HIP SYSTEM receive FDA 510(k) clearance?

DISTAL CENTRALIZER, EXETER II HIP SYSTEM received FDA 510(k) clearance on 1997-12-23, under 510(k) number K974054.

Who is the listed applicant for DISTAL CENTRALIZER, EXETER II HIP SYSTEM?

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

What is the FDA product code for DISTAL CENTRALIZER, EXETER II HIP SYSTEM?

The FDA product code for DISTAL CENTRALIZER, EXETER II HIP SYSTEM is JDI.

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Other records listing Howmedica, 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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