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FDA 510(k)

Titanium Interference Screws

K-Number: K193451 · 2020-02-24

ApplicantBiomet, Inc.
Decision Date2020-02-24
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Titanium Interference Screws is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2020-02-24 under 510(k) number K193451. 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 Titanium Interference Screws?

Titanium Interference Screws is a medical device that received FDA 510(k) clearance on 2020-02-24. The listed applicant is Biomet, Inc.. The 510(k) number is K193451.

When did Titanium Interference Screws receive FDA 510(k) clearance?

Titanium Interference Screws received FDA 510(k) clearance on 2020-02-24, under 510(k) number K193451.

Who is the listed applicant for Titanium Interference Screws?

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 Titanium Interference Screws?

The FDA product code for Titanium Interference Screws is HWC. This falls under the Cardiovascular category.

Other records listing Biomet, 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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