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FDA 510(k)

Arthrex FiberTape and TigerTape Cerclage Sutures

K-Number: K232755 · 2023-10-06

ApplicantArthrex, Inc.
Decision Date2023-10-06
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex FiberTape and TigerTape Cerclage Sutures is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K232755. 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 2023-10-06. The listed applicant is Arthrex, Inc.. The 510(k) number is K232755.

When did Arthrex FiberTape and TigerTape Cerclage Sutures receive FDA 510(k) clearance?

Arthrex FiberTape and TigerTape Cerclage Sutures received FDA 510(k) clearance on 2023-10-06, under 510(k) number K232755.

Who is the listed applicant for Arthrex FiberTape and TigerTape Cerclage Sutures?

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 FiberTape and TigerTape Cerclage Sutures?

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

Other records listing Arthrex, Inc. as applicant

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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.

K253115LARS ACJMovmedix S.A.S.K252081SportLinc Syndesmosis DeviceLincotek MedicalK253727Syndesmosis TightRope PROArthrex, Inc.K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)K251134RipCordTriMed, Inc.K243624Acu-Sinch Knotless MiniAcumed, LLC

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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