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FDA 510(k)

SOFT TISSUE SCREW AND WASHER

K-Number: K012572 · 2001-12-03

ApplicantBiomet, Inc.
Decision Date2001-12-03
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOFT TISSUE SCREW AND WASHER is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2001-12-03 under 510(k) number K012572. 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 SOFT TISSUE SCREW AND WASHER?

SOFT TISSUE SCREW AND WASHER is a medical device that received FDA 510(k) clearance on 2001-12-03. The listed applicant is Biomet, Inc.. The 510(k) number is K012572.

When did SOFT TISSUE SCREW AND WASHER receive FDA 510(k) clearance?

SOFT TISSUE SCREW AND WASHER received FDA 510(k) clearance on 2001-12-03, under 510(k) number K012572.

Who is the listed applicant for SOFT TISSUE SCREW AND WASHER?

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 SOFT TISSUE SCREW AND WASHER?

The FDA product code for SOFT TISSUE SCREW AND WASHER 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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