Name: Predicase
Price: 199 USD

K-number	K030581
Device name	BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
Applicant	Blackstone Medical, Inc.
Product code	MNH
Device class	Class II
Decision date	Jun 26, 2003
Decision	Substantially Equivalent
Regulation	888.3070

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Source

View the full FDA submission: accessdata.fda.gov

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BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)

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