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FDA 510(k)

Arthrex TightRope II

K-Number: K231857 · 2023-08-08

ApplicantArthrex, Inc.
Decision Date2023-08-08
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex TightRope II is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2023-08-08 under approval number K231857. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex TightRope II?

Arthrex TightRope II is a medical device that received FDA 510(k) clearance on 2023-08-08. It is manufactured by Arthrex, Inc.. The 510(k) number is K231857.

When was Arthrex TightRope II approved by the FDA?

Arthrex TightRope II received FDA 510(k) clearance on 2023-08-08, under approval number K231857.

What company makes Arthrex TightRope II?

Arthrex TightRope II is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex TightRope II?

The FDA product code for Arthrex TightRope II is MBI.

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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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