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FDA 510(k)

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)

K-Number: K243467 · 2024-12-03

ApplicantOsteonic Co., Ltd.
Decision Date2024-12-03
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) is a medical device manufactured by Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2024-12-03 under approval number K243467. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)?

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi 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 K243467.

When was Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) approved by the FDA?

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) received FDA 510(k) clearance on 2024-12-03, under approval number K243467.

What company makes Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)?

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) is manufactured by Osteonic Co., Ltd..

What is the FDA product code for Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)?

The FDA product code for Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) is MAI.

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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.

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