Name: Predicase
Price: 199 USD

K-number	K173104
Device name	Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly
Applicant	Total Joint Orthopedics, Inc.
Product code	OQG
Device class	Class II
Decision date	Oct 27, 2017
Decision	Substantially Equivalent
Regulation	888.3358

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Source

View the full FDA submission: accessdata.fda.gov

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Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly

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