Bone Screw Line Addition
K-Number: K191289 · 2019-07-29
ApplicantVilex IN Tennessee, Inc.
Decision Date2019-07-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Bone Screw Line Addition is a medical device manufactured by Vilex IN Tennessee, Inc.. It received FDA 510(k) clearance on 2019-07-29 under approval number K191289. 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 Bone Screw Line Addition?
Bone Screw Line Addition is a medical device that received FDA 510(k) clearance on 2019-07-29. It is manufactured by Vilex IN Tennessee, Inc.. The 510(k) number is K191289.
When was Bone Screw Line Addition approved by the FDA?
Bone Screw Line Addition received FDA 510(k) clearance on 2019-07-29, under approval number K191289.
What company makes Bone Screw Line Addition?
Bone Screw Line Addition is manufactured by Vilex IN Tennessee, Inc..
What is the FDA product code for Bone Screw Line Addition?
The FDA product code for Bone Screw Line Addition 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.