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FDA 510(k)

BIOMET TIBIAL LOCKING NAIL SYSTEM

K-Number: K063570 · 2007-02-27

ApplicantBiomet Manufacturing Corp
Decision Date2007-02-27
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOMET TIBIAL LOCKING NAIL SYSTEM 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 2007-02-27 under 510(k) number K063570. 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 BIOMET TIBIAL LOCKING NAIL SYSTEM?

BIOMET TIBIAL LOCKING NAIL SYSTEM is a medical device that received FDA 510(k) clearance on 2007-02-27. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K063570.

When did BIOMET TIBIAL LOCKING NAIL SYSTEM receive FDA 510(k) clearance?

BIOMET TIBIAL LOCKING NAIL SYSTEM received FDA 510(k) clearance on 2007-02-27, under 510(k) number K063570.

Who is the listed applicant for BIOMET TIBIAL LOCKING NAIL SYSTEM?

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 BIOMET TIBIAL LOCKING NAIL SYSTEM?

The FDA product code for BIOMET TIBIAL LOCKING NAIL SYSTEM 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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