Name: Predicase
Price: 199 USD

K-number	K123745
Device name	SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL
Applicant	Biomecanica Industria E Comerico DE Productos Orto
Product code	HSB
Device class	Class II
Decision date	Mar 25, 2013
Decision	Substantially Equivalent
Regulation	888.3020

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL

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