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FDA 510(k)

MINI TIGHTROPE

K-Number: K090107 · 2009-08-06

ApplicantArthrex, Inc.
Decision Date2009-08-06
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MINI TIGHTROPE is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2009-08-06 under 510(k) number K090107. 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?

MINI TIGHTROPE is a medical device that received FDA 510(k) clearance on 2009-08-06. The listed applicant is Arthrex, Inc.. The 510(k) number is K090107.

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

MINI TIGHTROPE received FDA 510(k) clearance on 2009-08-06, under 510(k) number K090107.

Who is the listed applicant for MINI TIGHTROPE?

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?

The FDA product code for MINI TIGHTROPE is HTN.

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Related Devices (Code: HTN)

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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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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