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FDA 510(k)

MICROMAX SUTURE ANCHOR

K-Number: K040475 · 2004-05-21

ApplicantBiomet, Inc.
Decision Date2004-05-21
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICROMAX SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2004-05-21 under 510(k) number K040475. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROMAX SUTURE ANCHOR?

MICROMAX SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 2004-05-21. The listed applicant is Biomet, Inc.. The 510(k) number is K040475.

When did MICROMAX SUTURE ANCHOR receive FDA 510(k) clearance?

MICROMAX SUTURE ANCHOR received FDA 510(k) clearance on 2004-05-21, under 510(k) number K040475.

Who is the listed applicant for MICROMAX SUTURE ANCHOR?

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

What is the FDA product code for MICROMAX SUTURE ANCHOR?

The FDA product code for MICROMAX SUTURE ANCHOR is HWC. This falls under the Cardiovascular category.

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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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