Name: Predicase
Price: 199 USD

K-number	K014145
Device name	MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131
Applicant	Interpore Cross Intl.
Product code	MQP
Device class	Class II
Decision date	Jan 17, 2002
Decision	Substantially Equivalent
Regulation	888.3060

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131

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