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FDA 510(k)

INTEGRA TOTAL WRIST FUSION SYSTEM

K-Number: K093163 · 2009-12-15

ApplicantIntegra LifeSciences Corporation
Decision Date2009-12-15
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTEGRA TOTAL WRIST FUSION SYSTEM 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 2009-12-15 under 510(k) number K093163. 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 WRIST FUSION SYSTEM?

INTEGRA TOTAL WRIST FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-12-15. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K093163.

When did INTEGRA TOTAL WRIST FUSION SYSTEM receive FDA 510(k) clearance?

INTEGRA TOTAL WRIST FUSION SYSTEM received FDA 510(k) clearance on 2009-12-15, under 510(k) number K093163.

Who is the listed applicant for INTEGRA TOTAL WRIST FUSION SYSTEM?

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 WRIST FUSION SYSTEM?

The FDA product code for INTEGRA TOTAL WRIST FUSION SYSTEM 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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