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FDA 510(k)

INTEGRA TOTAL FOOT SYSTEMS

K-Number: K123000 · 2012-12-21

ApplicantIntegra LifeSciences Corporation
Decision Date2012-12-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTEGRA TOTAL FOOT SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2012-12-21 under 510(k) number K123000. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRA TOTAL FOOT SYSTEMS?

INTEGRA TOTAL FOOT SYSTEMS is a medical device that received FDA 510(k) clearance on 2012-12-21. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K123000.

When did INTEGRA TOTAL FOOT SYSTEMS receive FDA 510(k) clearance?

INTEGRA TOTAL FOOT SYSTEMS received FDA 510(k) clearance on 2012-12-21, under 510(k) number K123000.

Who is the listed applicant for INTEGRA TOTAL FOOT SYSTEMS?

The FDA 510(k) record lists Integra LifeSciences Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTEGRA TOTAL FOOT SYSTEMS?

The FDA product code for INTEGRA TOTAL FOOT SYSTEMS is HRS.

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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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