510(k) K052062

ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES by Alliance Medical Corp. — Product Code KTT

K052062 is an FDA 510(k) premarket notification submitted by Alliance Medical Corp. for the device "ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES". The FDA issued a decision of Substantially Equivalent on August 25, 2005. 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. Alliance Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2005
Date Received
July 29, 2005
Clearance Type
Special
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