510(k) K060731

EVOLVE MODULAR RADIAL HEAD by Wrightmedicaltechnologyinc — Product Code KWI

K060731 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "EVOLVE MODULAR RADIAL HEAD". The FDA issued a decision of Substantially Equivalent on April 19, 2006. The device falls under product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer), a Class II device regulated under 21 CFR 888.3170. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.

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