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FDA 510(k)

RESORBABLE NO PROFILE SCREW AND WASHER

K-Number: K012469 · 2001-12-03

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

Device Summary

RESORBABLE NO PROFILE SCREW AND WASHER is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing, Inc.. It received FDA 510(k) clearance on 2001-12-03 under 510(k) number K012469. 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 RESORBABLE NO PROFILE SCREW AND WASHER?

RESORBABLE NO PROFILE SCREW AND WASHER is a medical device that received FDA 510(k) clearance on 2001-12-03. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K012469.

When did RESORBABLE NO PROFILE SCREW AND WASHER receive FDA 510(k) clearance?

RESORBABLE NO PROFILE SCREW AND WASHER received FDA 510(k) clearance on 2001-12-03, under 510(k) number K012469.

Who is the listed applicant for RESORBABLE NO PROFILE SCREW AND WASHER?

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

What is the FDA product code for RESORBABLE NO PROFILE SCREW AND WASHER?

The FDA product code for RESORBABLE NO PROFILE 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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