Name: Predicase
Price: 199 USD

K-number	K952471
Device name	BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD
Applicant	Bioscience, Inc.
Product code	MAI
Device class	Class II
Decision date	Aug 7, 1995
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD

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