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FDA 510(k)

TENDON WRAP TENDON PROTECTOR

K-Number: K053655 · 2006-02-03

ApplicantIntegra LifeSciences Corporation
Decision Date2006-02-03
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TENDON WRAP TENDON PROTECTOR 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 2006-02-03 under 510(k) number K053655. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENDON WRAP TENDON PROTECTOR?

TENDON WRAP TENDON PROTECTOR is a medical device that received FDA 510(k) clearance on 2006-02-03. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K053655.

When did TENDON WRAP TENDON PROTECTOR receive FDA 510(k) clearance?

TENDON WRAP TENDON PROTECTOR received FDA 510(k) clearance on 2006-02-03, under 510(k) number K053655.

Who is the listed applicant for TENDON WRAP TENDON PROTECTOR?

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 TENDON WRAP TENDON PROTECTOR?

The FDA product code for TENDON WRAP TENDON PROTECTOR is FTM.

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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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