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FDA 510(k)

22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD

K-Number: K970846 · 1997-06-05

ApplicantLandos, Inc.
Decision Date1997-06-05
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Landos, Inc.. It received FDA 510(k) clearance on 1997-06-05 under 510(k) number K970846. 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 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD?

22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 1997-06-05. The listed applicant is Landos, Inc.. The 510(k) number is K970846.

When did 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD receive FDA 510(k) clearance?

22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD received FDA 510(k) clearance on 1997-06-05, under 510(k) number K970846.

Who is the listed applicant for 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD?

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

What is the FDA product code for 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD?

The FDA product code for 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD is LZO.

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Other records listing Landos, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K964226MEMORY STAPLE (20 SIZES AVAILABLE)K971069TWIST-OFF (TM) SCREWK971070SCARF THREAD-HEAD (TM) HEAD SCREWK97106834MM SCARF THREAD-HEAD(TM) SCREWK961732KARK953111CORAIL

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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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