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FDA 510(k)

MIMIX BONE REPLACEMENT SYSTEM

K-Number: K003494 · 2001-04-09

ApplicantBiomet, Inc.
Decision Date2001-04-09
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIMIX BONE REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2001-04-09 under 510(k) number K003494. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIMIX BONE REPLACEMENT SYSTEM?

MIMIX BONE REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2001-04-09. The listed applicant is Biomet, Inc.. The 510(k) number is K003494.

When did MIMIX BONE REPLACEMENT SYSTEM receive FDA 510(k) clearance?

MIMIX BONE REPLACEMENT SYSTEM received FDA 510(k) clearance on 2001-04-09, under 510(k) number K003494.

Who is the listed applicant for MIMIX BONE REPLACEMENT SYSTEM?

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 MIMIX BONE REPLACEMENT SYSTEM?

The FDA product code for MIMIX BONE REPLACEMENT SYSTEM is LYC.

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Related Devices (Code: LYC)

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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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