Suture Wing
K-Number: K233659 · 2023-12-26
ApplicantOsteonic Co., Ltd.
Decision Date2023-12-26
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Suture Wing is a medical device manufactured by Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2023-12-26 under approval number K233659. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Suture Wing?
Suture Wing is a medical device that received FDA 510(k) clearance on 2023-12-26. It is manufactured by Osteonic Co., Ltd.. The 510(k) number is K233659.
When was Suture Wing approved by the FDA?
Suture Wing received FDA 510(k) clearance on 2023-12-26, under approval number K233659.
What company makes Suture Wing?
Suture Wing is manufactured by Osteonic Co., Ltd..
What is the FDA product code for Suture Wing?
The FDA product code for Suture Wing is MBI.
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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.