510(k) K060731

EVOLVE MODULAR RADIAL HEAD by Wrightmedicaltechnologyinc — Product Code KWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2006
Date Received
March 20, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class
Class II
Regulation Number
888.3170
Review Panel
OR
Submission Type