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FDA 510(k)

REUNITE SCREWS

K-Number: K992301 · 1999-09-01

ApplicantBiomet Manufacturing, Inc.
Decision Date1999-09-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REUNITE SCREWS 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 1999-09-01 under 510(k) number K992301. 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 REUNITE SCREWS?

REUNITE SCREWS is a medical device that received FDA 510(k) clearance on 1999-09-01. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K992301.

When did REUNITE SCREWS receive FDA 510(k) clearance?

REUNITE SCREWS received FDA 510(k) clearance on 1999-09-01, under 510(k) number K992301.

Who is the listed applicant for REUNITE SCREWS?

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 REUNITE SCREWS?

The FDA product code for REUNITE SCREWS is HWC. This falls under the Cardiovascular category.

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Other records listing Biomet Manufacturing, Inc. 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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