LTJ Screws and Washer
K-Number: K200987 · 2020-09-22
ApplicantAzurmeds, Inc.
Decision Date2020-09-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
LTJ Screws and Washer is a medical device manufactured by Azurmeds, Inc.. It received FDA 510(k) clearance on 2020-09-22 under approval number K200987. 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 LTJ Screws and Washer?
LTJ Screws and Washer is a medical device that received FDA 510(k) clearance on 2020-09-22. It is manufactured by Azurmeds, Inc.. The 510(k) number is K200987.
When was LTJ Screws and Washer approved by the FDA?
LTJ Screws and Washer received FDA 510(k) clearance on 2020-09-22, under approval number K200987.
What company makes LTJ Screws and Washer?
LTJ Screws and Washer is manufactured by Azurmeds, Inc..
What is the FDA product code for LTJ Screws and Washer?
The FDA product code for LTJ Screws 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.