EVOLVE CERAMIC RADIAL HEAD IMPLANT


Device Classification Name

prosthesis, elbow, hemi-, radial, polymer

510(k) Number K030384
Device Name EVOLVE CERAMIC RADIAL HEAD IMPLANT
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Applicant Contact jeanine h redden
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Correspodent Contact jeanine h redden
Regulation Number 888.3170
Classification Product Code
KWI  
Date Received 02/05/2003
Decision Date 08/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No