Fixone Biocomposite Interference Screw
K-Number: K193497 · 2021-01-05
ApplicantAju Pharm Co., Ltd.
Decision Date2021-01-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Fixone Biocomposite Interference Screw is a medical device manufactured by Aju Pharm Co., Ltd.. It received FDA 510(k) clearance on 2021-01-05 under approval number K193497. 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 Fixone Biocomposite Interference Screw?
Fixone Biocomposite Interference Screw is a medical device that received FDA 510(k) clearance on 2021-01-05. It is manufactured by Aju Pharm Co., Ltd.. The 510(k) number is K193497.
When was Fixone Biocomposite Interference Screw approved by the FDA?
Fixone Biocomposite Interference Screw received FDA 510(k) clearance on 2021-01-05, under approval number K193497.
What company makes Fixone Biocomposite Interference Screw?
Fixone Biocomposite Interference Screw is manufactured by Aju Pharm Co., Ltd..
What is the FDA product code for Fixone Biocomposite Interference Screw?
The FDA product code for Fixone Biocomposite Interference 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.