PROFEMUR LX REVISION 5/8 COATED HIP STEM


Device Classification Name

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

510(k) Number K080663
Device Name PROFEMUR LX REVISION 5/8 COATED HIP STEM
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Applicant Contact ryan ross
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Correspodent Contact ryan ross
Regulation Number 888.3330
Classification Product Code
KWA  
Subsequent Product Codes
LZO   MBL  
Date Received 03/10/2008
Decision Date 04/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No