Name: Predicase
Price: 199 USD

K-number	K970258
Device name	FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES
Applicant	Ferguson Medical
Product code	HRS
Device class	Class II
Decision date	May 22, 1997
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES

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