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FDA 510(k)

COAXIAL APPLICATOR SYSTEM

K-Number: K091722 · 2010-03-12

ApplicantBiomet, Inc.
Decision Date2010-03-12
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COAXIAL APPLICATOR 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 2010-03-12 under 510(k) number K091722. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAXIAL APPLICATOR SYSTEM?

COAXIAL APPLICATOR SYSTEM is a medical device that received FDA 510(k) clearance on 2010-03-12. The listed applicant is Biomet, Inc.. The 510(k) number is K091722.

When did COAXIAL APPLICATOR SYSTEM receive FDA 510(k) clearance?

COAXIAL APPLICATOR SYSTEM received FDA 510(k) clearance on 2010-03-12, under 510(k) number K091722.

Who is the listed applicant for COAXIAL APPLICATOR 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 COAXIAL APPLICATOR SYSTEM?

The FDA product code for COAXIAL APPLICATOR SYSTEM is FMF.

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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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