Auxilock Titanium Interference Screw
K-Number: K203029 · 2021-08-20
ApplicantAuxein Medical Private Limited
Decision Date2021-08-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Auxilock Titanium Interference Screw is a medical device manufactured by Auxein Medical Private Limited. It received FDA 510(k) clearance on 2021-08-20 under approval number K203029. 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 Auxilock Titanium Interference Screw?
Auxilock Titanium Interference Screw is a medical device that received FDA 510(k) clearance on 2021-08-20. It is manufactured by Auxein Medical Private Limited. The 510(k) number is K203029.
When was Auxilock Titanium Interference Screw approved by the FDA?
Auxilock Titanium Interference Screw received FDA 510(k) clearance on 2021-08-20, under approval number K203029.
What company makes Auxilock Titanium Interference Screw?
Auxilock Titanium Interference Screw is manufactured by Auxein Medical Private Limited.
What is the FDA product code for Auxilock Titanium Interference Screw?
The FDA product code for Auxilock Titanium Interference Screw is HWC. This falls under the Cardiovascular category.
Related PubMed Literature
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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.