PROFEMUR(R) E CEMENTLESS HIP STEM


Device Classification Name

prosthesis, hip, semi-constrained (metal uncemented acetabular component)

510(k) Number K111698
Device Name PROFEMUR(R) E CEMENTLESS HIP STEM
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Applicant Contact gregory neal
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Correspodent Contact gregory neal
Regulation Number 888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDL   LPH   LZO  
Date Received 06/17/2011
Decision Date 08/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls