Name: Predicase
Price: 199 USD

K-number	K143085
Device name	Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach
Applicant	Stryker Orthopaedics
Product code	LPH
Device class	Class II
Decision date	Feb 9, 2015
Decision	Substantially Equivalent
Regulation	888.3358

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Source

View the full FDA submission: accessdata.fda.gov

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Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach

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