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FDA 510(k)

ARTHREX KNOTLESS SUTURETAK ANCHOR

K-Number: K120155 · 2012-02-17

ApplicantArthrex, Inc.
Decision Date2012-02-17
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX KNOTLESS SUTURETAK 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 2012-02-17 under 510(k) number K120155. 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 SUTURETAK ANCHOR?

ARTHREX KNOTLESS SUTURETAK ANCHOR is a medical device that received FDA 510(k) clearance on 2012-02-17. The listed applicant is Arthrex, Inc.. The 510(k) number is K120155.

When did ARTHREX KNOTLESS SUTURETAK ANCHOR receive FDA 510(k) clearance?

ARTHREX KNOTLESS SUTURETAK ANCHOR received FDA 510(k) clearance on 2012-02-17, under 510(k) number K120155.

Who is the listed applicant for ARTHREX KNOTLESS SUTURETAK 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 SUTURETAK ANCHOR?

The FDA product code for ARTHREX KNOTLESS SUTURETAK ANCHOR is MBI.

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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.

K262975Arthrex Beaming SystemK262618Arthrex Spine Compression FT ScrewK262451Arthrex DynaNite StaplesK262357Arthrex Bioabsorbable PushLock Suture AnchorsK260624Arthrex Radial Head Replacement SystemK260018Arthrex FiberButton

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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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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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