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FDA 510(k)

VANGUARD REMOVABLE MOLDED POLY TIBIA

K-Number: K102580 · 2011-03-03

ApplicantBiomet Manufacturing Corp
Decision Date2011-03-03
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VANGUARD REMOVABLE MOLDED POLY TIBIA is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2011-03-03 under 510(k) number K102580. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VANGUARD REMOVABLE MOLDED POLY TIBIA?

VANGUARD REMOVABLE MOLDED POLY TIBIA is a medical device that received FDA 510(k) clearance on 2011-03-03. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K102580.

When did VANGUARD REMOVABLE MOLDED POLY TIBIA receive FDA 510(k) clearance?

VANGUARD REMOVABLE MOLDED POLY TIBIA received FDA 510(k) clearance on 2011-03-03, under 510(k) number K102580.

Who is the listed applicant for VANGUARD REMOVABLE MOLDED POLY TIBIA?

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

What is the FDA product code for VANGUARD REMOVABLE MOLDED POLY TIBIA?

The FDA product code for VANGUARD REMOVABLE MOLDED POLY TIBIA is JWH.

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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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