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FDA 510(k)

Arthrex Knotless FiberTak Biceps Suture Anchor

K-Number: K222161 · 2022-08-11

ApplicantArthrex, Inc.
Decision Date2022-08-11
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Knotless FiberTak Biceps Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2022-08-11 under 510(k) number K222161. 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 Knotless FiberTak Biceps Suture Anchor?

Arthrex Knotless FiberTak Biceps Suture Anchor is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is Arthrex, Inc.. The 510(k) number is K222161.

When did Arthrex Knotless FiberTak Biceps Suture Anchor receive FDA 510(k) clearance?

Arthrex Knotless FiberTak Biceps Suture Anchor received FDA 510(k) clearance on 2022-08-11, under 510(k) number K222161.

Who is the listed applicant for Arthrex Knotless FiberTak Biceps Suture Anchor?

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 Knotless FiberTak Biceps Suture Anchor?

The FDA product code for Arthrex Knotless FiberTak Biceps Suture Anchor is MBI.

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.

NCT05753891Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)TERMINATEDNCT06829667Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle InstabilityCOMPLETEDNCT04552119Safety of Treatment of Shoulder RepairCOMPLETED

Other records listing Arthrex, Inc. as applicant

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.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsK260624Arthrex Radial Head Replacement SystemK260018Arthrex FiberButtonK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemK253931Arthrex Bioabsorbable PushLock Suture AnchorsK254215Arthrex Beaming System

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Related Devices (Code: MBI)

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.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

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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