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FDA 510(k)

HOWMEDICA SENTRY S TOTAL HIP SYSTEM

K-Number: K935913 · 1994-12-15

ApplicantHowmedica, Inc.
Decision Date1994-12-15
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOWMEDICA SENTRY S TOTAL 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 1994-12-15 under 510(k) number K935913. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOWMEDICA SENTRY S TOTAL HIP SYSTEM?

HOWMEDICA SENTRY S TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1994-12-15. The listed applicant is Howmedica, Inc.. The 510(k) number is K935913.

When did HOWMEDICA SENTRY S TOTAL HIP SYSTEM receive FDA 510(k) clearance?

HOWMEDICA SENTRY S TOTAL HIP SYSTEM received FDA 510(k) clearance on 1994-12-15, under 510(k) number K935913.

Who is the listed applicant for HOWMEDICA SENTRY S TOTAL 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 HOWMEDICA SENTRY S TOTAL HIP SYSTEM?

The FDA product code for HOWMEDICA SENTRY S TOTAL HIP SYSTEM is LZO.

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Other records listing Howmedica, Inc. as applicant

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Related Devices (Code: LZO)

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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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