Name: Predicase
Price: 199 USD

K-number	K161840
Device name	LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated
Applicant	Waldemar Link GmbH & Co. KG
Product code	LZO
Device class	Class II
Decision date	Mar 16, 2017
Decision	Substantially Equivalent
Regulation	888.3353

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Source

View the full FDA submission: accessdata.fda.gov

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LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated

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