ATH FEMORAL STEM

Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, cemented

510(k) Number K034028
Device Name ATH FEMORAL STEM
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 888.3350
Classification Product Code
JDI  
Subsequent Product Code
LPH  
Date Received 12/29/2003
Decision Date 03/11/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No