Injection Screw
K-Number: K173556 · 2018-07-13
ApplicantBiedermann Medtech, Inc.
Decision Date2018-07-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Injection Screw is a medical device manufactured by Biedermann Medtech, Inc.. It received FDA 510(k) clearance on 2018-07-13 under approval number K173556. 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 Injection Screw?
Injection Screw is a medical device that received FDA 510(k) clearance on 2018-07-13. It is manufactured by Biedermann Medtech, Inc.. The 510(k) number is K173556.
When was Injection Screw approved by the FDA?
Injection Screw received FDA 510(k) clearance on 2018-07-13, under approval number K173556.
What company makes Injection Screw?
Injection Screw is manufactured by Biedermann Medtech, Inc..
What is the FDA product code for Injection Screw?
The FDA product code for Injection Screw 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.