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 a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2020-02-24 under approval 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. It is manufactured by Biomet, Inc.. The 510(k) number is K193451.
When was Titanium Interference Screws approved by the FDA?
Titanium Interference Screws received FDA 510(k) clearance on 2020-02-24, under approval number K193451.
What company makes Titanium Interference Screws?
Titanium Interference Screws is manufactured by Biomet, Inc..
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.
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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.