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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 the device name listed in this FDA 510(k) record. The listed applicant is Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2024-12-03 under 510(k) 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. The listed applicant is Osteonic Co., Ltd.. The 510(k) number is K243467.

When did Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) receive FDA 510(k) clearance?

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

Who is the listed applicant for Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)?

The FDA 510(k) record lists Osteonic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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