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FDA 510(k)

BROOKER TIBIA NAILS

K-Number: K002057 · 2000-10-04

ApplicantBiomet Orthopedics, Inc.
Decision Date2000-10-04
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BROOKER TIBIA NAILS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics, Inc.. It received FDA 510(k) clearance on 2000-10-04 under 510(k) number K002057. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BROOKER TIBIA NAILS?

BROOKER TIBIA NAILS is a medical device that received FDA 510(k) clearance on 2000-10-04. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K002057.

When did BROOKER TIBIA NAILS receive FDA 510(k) clearance?

BROOKER TIBIA NAILS received FDA 510(k) clearance on 2000-10-04, under 510(k) number K002057.

Who is the listed applicant for BROOKER TIBIA NAILS?

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

What is the FDA product code for BROOKER TIBIA NAILS?

The FDA product code for BROOKER TIBIA NAILS is HSB.

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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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