Name: Predicase
Price: 199 USD

K-number	K232251
Device name	APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension
Applicant	Medartis AG
Product code	HWC
Device class	Class II
Decision date	Nov 3, 2023
Decision	Substantially Equivalent
Regulation	888.3040

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension

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