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FDA 510(k)

PCL TIGHTROPE

K-Number: K110123 · 2011-04-28

ApplicantArthrex, Inc.
Decision Date2011-04-28
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PCL 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 2011-04-28 under 510(k) number K110123. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PCL TIGHTROPE?

PCL TIGHTROPE is a medical device that received FDA 510(k) clearance on 2011-04-28. The listed applicant is Arthrex, Inc.. The 510(k) number is K110123.

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

PCL TIGHTROPE received FDA 510(k) clearance on 2011-04-28, under 510(k) number K110123.

Who is the listed applicant for PCL 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 PCL TIGHTROPE?

The FDA product code for PCL TIGHTROPE is HTY.

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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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