Name: Predicase
Price: 199 USD

K-number	K180612
Device name	Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
Applicant	Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Product code	HSX
Device class	Class II
Decision date	Jun 7, 2018
Decision	Substantially Equivalent
Regulation	888.3520

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Source

View the full FDA submission: accessdata.fda.gov

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Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts

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