510(k) K090374

STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S by DePuy Orthopaedics, Inc. — Product Code LXT

K090374 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S". The FDA issued a decision of Substantially Equivalent on March 11, 2009. The device falls under product code LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite), a Class II device regulated under 21 CFR 888.3030. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2009
Date Received
February 17, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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