Name: Predicase
Price: 199 USD

K-number	K243467
Device name	Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
Applicant	Osteonic Co., Ltd.
Product code	MAI
Device class	Class II
Decision date	Dec 3, 2024
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.