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FDA 510(k)

BIOMET FEMORAL LOCKING NAIL SYSTEM

K-Number: K072161 · 2007-09-20

Decision Date2007-09-20
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOMET FEMORAL 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 2007-09-20 under 510(k) number K072161. 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 FEMORAL LOCKING NAIL SYSTEM?

BIOMET FEMORAL LOCKING NAIL SYSTEM is a medical device that received FDA 510(k) clearance on 2007-09-20. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K072161.

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

BIOMET FEMORAL LOCKING NAIL SYSTEM received FDA 510(k) clearance on 2007-09-20, under 510(k) number K072161.

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

The FDA product code for BIOMET FEMORAL LOCKING NAIL SYSTEM is HSB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Biomet Manufacturing Corp as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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