510(k) K093057

BIOMET VISION FOOTRING SYSTEM by Ebi, L.P. — Product Code KTT

K093057 is an FDA 510(k) premarket notification submitted by Ebi, L.P. for the device "BIOMET VISION FOOTRING SYSTEM". The FDA issued a decision of Substantially Equivalent on December 1, 2009. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. Ebi, L.P. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2009
Date Received
September 30, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type