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FDA 510(k)

ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)

K-Number: K943586 · 1994-10-17

ApplicantBiomet, Inc.
Decision Date1994-10-17
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET) is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1994-10-17 under 510(k) number K943586. 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 CERAMIC MODULAR HEADS (ASTRO MET)?

ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET) is a medical device that received FDA 510(k) clearance on 1994-10-17. The listed applicant is Biomet, Inc.. The 510(k) number is K943586.

When did ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET) receive FDA 510(k) clearance?

ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET) received FDA 510(k) clearance on 1994-10-17, under 510(k) number K943586.

Who is the listed applicant for ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)?

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 CERAMIC MODULAR HEADS (ASTRO MET)?

The FDA product code for ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET) 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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