Name: Predicase
Price: 199 USD

K-number	K030972
Device name	FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)
Applicant	Disc-O-Tech Medical Technologies, Ltd.
Product code	KWL
Device class	Class II
Decision date	May 30, 2003
Decision	Substantially Equivalent
Regulation	888.3360

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Source

View the full FDA submission: accessdata.fda.gov

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FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)

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