510(k) K113387

CITIEFFE TITANIUM NAILING SYSTEM by Citieffe — Product Code HSB

K113387 is an FDA 510(k) premarket notification submitted by Citieffe for the device "CITIEFFE TITANIUM NAILING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 15, 2012. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Citieffe has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2012
Date Received
November 16, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type