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FDA 510(k)

ZIRCONIA 22.22MM CERAMIC MODULAR HEADS

K-Number: K991708 · 1999-07-30

ApplicantBiomet, Inc.
Decision Date1999-07-30
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZIRCONIA 22.22MM CERAMIC MODULAR HEADS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1999-07-30 under 510(k) number K991708. 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 ZIRCONIA 22.22MM CERAMIC MODULAR HEADS?

ZIRCONIA 22.22MM CERAMIC MODULAR HEADS is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is Biomet, Inc.. The 510(k) number is K991708.

When did ZIRCONIA 22.22MM CERAMIC MODULAR HEADS receive FDA 510(k) clearance?

ZIRCONIA 22.22MM CERAMIC MODULAR HEADS received FDA 510(k) clearance on 1999-07-30, under 510(k) number K991708.

Who is the listed applicant for ZIRCONIA 22.22MM CERAMIC MODULAR HEADS?

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

What is the FDA product code for ZIRCONIA 22.22MM CERAMIC MODULAR HEADS?

The FDA product code for ZIRCONIA 22.22MM CERAMIC MODULAR HEADS is LZO.

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Other records listing Biomet, 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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