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FDA 510(k)

Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II

K-Number: K221128 · 2022-10-05

ApplicantArthrex, Inc.
Decision Date2022-10-05
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2022-10-05 under 510(k) number K221128. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II?

Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II is a medical device that received FDA 510(k) clearance on 2022-10-05. The listed applicant is Arthrex, Inc.. The 510(k) number is K221128.

When did Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II receive FDA 510(k) clearance?

Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II received FDA 510(k) clearance on 2022-10-05, under 510(k) number K221128.

Who is the listed applicant for Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II?

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 Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II?

The FDA product code for Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II is MAI.

Related Clinical Trials

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.

NCT07553975Randomized Arthrex Nano Arthroscopy in Arthroscopic ACL vs Conventional ArthroscopyNOT_YET_RECRUITING

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Related Devices (Code: MAI)

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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