Name: Predicase
Price: 199 USD

K-number	K231819
Device name	Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
Applicant	Innovate Orthopaedics Limited
Product code	HWC
Device class	Class II
Decision date	Sep 5, 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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Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

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