510(k) K093707

DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820 by U&I Corp. — Product Code HSB

K093707 is an FDA 510(k) premarket notification submitted by U&I Corp. for the device "DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820". The FDA issued a decision of Substantially Equivalent on June 23, 2010. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. U&I Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2010
Date Received
December 2, 2009
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