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FDA 510(k)

Arthrex FiberTape and TigerTape Cerclage Sutures

K-Number: K221485 · 2022-08-22

ApplicantArthrex, Inc.
Decision Date2022-08-22
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex FiberTape and TigerTape Cerclage Sutures is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2022-08-22 under approval number K221485. 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 Arthrex FiberTape and TigerTape Cerclage Sutures?

Arthrex FiberTape and TigerTape Cerclage Sutures is a medical device that received FDA 510(k) clearance on 2022-08-22. It is manufactured by Arthrex, Inc.. The 510(k) number is K221485.

When was Arthrex FiberTape and TigerTape Cerclage Sutures approved by the FDA?

Arthrex FiberTape and TigerTape Cerclage Sutures received FDA 510(k) clearance on 2022-08-22, under approval number K221485.

What company makes Arthrex FiberTape and TigerTape Cerclage Sutures?

Arthrex FiberTape and TigerTape Cerclage Sutures is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex FiberTape and TigerTape Cerclage Sutures?

The FDA product code for Arthrex FiberTape and TigerTape Cerclage Sutures is 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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