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FDA 510(k)

MITEK KNOTLESS ANCHOR

K-Number: K974345 · 1998-02-13

ApplicantMitek Products
Decision Date1998-02-13
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MITEK KNOTLESS ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Products. It received FDA 510(k) clearance on 1998-02-13 under 510(k) number K974345. 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 MITEK KNOTLESS ANCHOR?

MITEK KNOTLESS ANCHOR is a medical device that received FDA 510(k) clearance on 1998-02-13. The listed applicant is Mitek Products. The 510(k) number is K974345.

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

MITEK KNOTLESS ANCHOR received FDA 510(k) clearance on 1998-02-13, under 510(k) number K974345.

Who is the listed applicant for MITEK KNOTLESS ANCHOR?

The FDA 510(k) record lists Mitek Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MITEK KNOTLESS ANCHOR?

The FDA product code for MITEK KNOTLESS ANCHOR is MBI.

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Other records listing Mitek Products 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.

K013572MITEK BIOCRYL INTERFERENCE SCREWSK013781RIDIDFIX 2.7MM BTB CROSS PIN KITK002639BIOKNOTLESS ANCHORK010633RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEMK002406MITEK 2GII MENISCAL REPAIR SYSTEMK003076MITEK CUFFTACK

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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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