Name: Predicase
Price: 199 USD

K-number	K012871
Device name	SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177
Applicant	Interpore Cross Intl.
Product code	KWP
Device class	Class II
Decision date	Sep 13, 2001
Decision	Substantially Equivalent
Regulation	888.3050

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Source

View the full FDA submission: accessdata.fda.gov

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SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177

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