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FDA 510(k)

A.I.M. SUTURE ANCHOR

K-Number: K132461 · 2013-10-16

ApplicantAnchor Innovation Medical, Inc.
Decision Date2013-10-16
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

A.I.M. SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Anchor Innovation Medical, Inc.. It received FDA 510(k) clearance on 2013-10-16 under 510(k) number K132461. 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 A.I.M. SUTURE ANCHOR?

A.I.M. SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 2013-10-16. The listed applicant is Anchor Innovation Medical, Inc.. The 510(k) number is K132461.

When did A.I.M. SUTURE ANCHOR receive FDA 510(k) clearance?

A.I.M. SUTURE ANCHOR received FDA 510(k) clearance on 2013-10-16, under 510(k) number K132461.

Who is the listed applicant for A.I.M. SUTURE ANCHOR?

The FDA 510(k) record lists Anchor Innovation Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A.I.M. SUTURE ANCHOR?

The FDA product code for A.I.M. SUTURE ANCHOR is MBI.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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