Name: Predicase
Price: 199 USD

K-number	K091253
Device name	THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS
Applicant	K2m, Inc.
Product code	KWQ
Device class	Class II
Decision date	Jun 4, 2009
Decision	Substantially Equivalent
Regulation	888.3060

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Source

View the full FDA submission: accessdata.fda.gov

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THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS

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