Name: Predicase
Price: 199 USD

K-number	K081758
Device name	HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015
Applicant	Depuy Spine, Inc.
Product code	MQV
Device class	Class II
Decision date	Sep 3, 2008
Decision	Substantially Equivalent
Regulation	888.3045

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Source

View the full FDA submission: accessdata.fda.gov

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HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015

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