Name: Predicase
Price: 199 USD

K-number	K033411
Device name	SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS
Applicant	Synthes (Usa)
Product code	KTT
Device class	Class II
Decision date	Nov 26, 2003
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS

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