Name: Predicase
Price: 199 USD

K-number	K172587
Device name	Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers
Applicant	Medacta International S.A.
Product code	ODP
Device class	Class II
Decision date	Sep 18, 2017
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers

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