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FDA 510(k)

MINI TIGHTROPE FT REPAIR KIT

K-Number: K071978 · 2007-08-15

ApplicantArthrex, Inc.
Decision Date2007-08-15
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MINI TIGHTROPE FT REPAIR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2007-08-15 under 510(k) number K071978. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINI TIGHTROPE FT REPAIR KIT?

MINI TIGHTROPE FT REPAIR KIT is a medical device that received FDA 510(k) clearance on 2007-08-15. The listed applicant is Arthrex, Inc.. The 510(k) number is K071978.

When did MINI TIGHTROPE FT REPAIR KIT receive FDA 510(k) clearance?

MINI TIGHTROPE FT REPAIR KIT received FDA 510(k) clearance on 2007-08-15, under 510(k) number K071978.

Who is the listed applicant for MINI TIGHTROPE FT REPAIR KIT?

The FDA 510(k) record lists Arthrex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINI TIGHTROPE FT REPAIR KIT?

The FDA product code for MINI TIGHTROPE FT REPAIR KIT is HTN.

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Related Devices (Code: HTN)

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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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