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FDA 510(k)

MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR

K-Number: K070925 · 2007-05-02

ApplicantDepuy Mitek, A Johnson & Johnson Company
Decision Date2007-05-02
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. It received FDA 510(k) clearance on 2007-05-02 under 510(k) number K070925. 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 MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR?

MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR is a medical device that received FDA 510(k) clearance on 2007-05-02. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. The 510(k) number is K070925.

When did MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR receive FDA 510(k) clearance?

MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR received FDA 510(k) clearance on 2007-05-02, under 510(k) number K070925.

Who is the listed applicant for MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR?

The FDA 510(k) record lists Depuy Mitek, A Johnson & Johnson Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR?

The FDA product code for MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR is MAI.

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Other records listing Depuy Mitek, A Johnson & Johnson Company as applicant

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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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