Name: Predicase
Price: 199 USD

K-number	K162179
Device name	osteo-WEDGE II ® Open Wedge Bone Locking Plate System
Applicant	Graham Medical Technologies, LLC Dba Gramedica
Product code	HRS
Device class	Class II
Decision date	Jan 10, 2017
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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osteo-WEDGE II ® Open Wedge Bone Locking Plate System

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