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FDA 510(k)

MITEK ABSORBABLE TOGGLE ANCHOR

K-Number: K964013 · 1997-02-24

ApplicantMitek Products
Decision Date1997-02-24
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MITEK ABSORBABLE TOGGLE 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 1997-02-24 under 510(k) number K964013. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MITEK ABSORBABLE TOGGLE ANCHOR?

MITEK ABSORBABLE TOGGLE ANCHOR is a medical device that received FDA 510(k) clearance on 1997-02-24. The listed applicant is Mitek Products. The 510(k) number is K964013.

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

MITEK ABSORBABLE TOGGLE ANCHOR received FDA 510(k) clearance on 1997-02-24, under 510(k) number K964013.

Who is the listed applicant for MITEK ABSORBABLE TOGGLE 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 ABSORBABLE TOGGLE ANCHOR?

The FDA product code for MITEK ABSORBABLE TOGGLE ANCHOR is MAI.

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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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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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