Fix2Lock (PEEK Self Punching)
K-Number: K243470 · 2024-12-03
ApplicantOsteonic Co., Ltd.
Decision Date2024-12-03
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Fix2Lock (PEEK Self Punching) is a medical device manufactured by Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2024-12-03 under approval number K243470. 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 Fix2Lock (PEEK Self Punching)?
Fix2Lock (PEEK Self Punching) is a medical device that received FDA 510(k) clearance on 2024-12-03. It is manufactured by Osteonic Co., Ltd.. The 510(k) number is K243470.
When was Fix2Lock (PEEK Self Punching) approved by the FDA?
Fix2Lock (PEEK Self Punching) received FDA 510(k) clearance on 2024-12-03, under approval number K243470.
What company makes Fix2Lock (PEEK Self Punching)?
Fix2Lock (PEEK Self Punching) is manufactured by Osteonic Co., Ltd..
What is the FDA product code for Fix2Lock (PEEK Self Punching)?
The FDA product code for Fix2Lock (PEEK Self Punching) 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.