Name: Predicase
Price: 199 USD

K-number	K180239
Device name	Additive Orthopaedics Patient Specific 3D Printed Bone Segments
Applicant	Additive Orthopaedics, LLC
Product code	HRS
Device class	Class II
Decision date	May 16, 2018
Decision	Substantially Equivalent
Regulation	888.3030

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Additive Orthopaedics Patient Specific 3D Printed Bone Segments

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