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FDA 510(k)

MERIDIAN TITANIUM FEMORAL STEMS

K-Number: K972228 · 1997-12-05

ApplicantHowmedica, Inc.
Decision Date1997-12-05
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

MERIDIAN TITANIUM FEMORAL STEMS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica, Inc.. It received FDA 510(k) clearance on 1997-12-05 under 510(k) number K972228. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MERIDIAN TITANIUM FEMORAL STEMS?

MERIDIAN TITANIUM FEMORAL STEMS is a medical device that received FDA 510(k) clearance on 1997-12-05. The listed applicant is Howmedica, Inc.. The 510(k) number is K972228.

When did MERIDIAN TITANIUM FEMORAL STEMS receive FDA 510(k) clearance?

MERIDIAN TITANIUM FEMORAL STEMS received FDA 510(k) clearance on 1997-12-05, under 510(k) number K972228.

Who is the listed applicant for MERIDIAN TITANIUM FEMORAL STEMS?

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 MERIDIAN TITANIUM FEMORAL STEMS?

The FDA product code for MERIDIAN TITANIUM FEMORAL STEMS is 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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