PROFEMUR GLADIATOR HA HIP STEM


Device Classification Name

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

510(k) Number K112150
Device Name PROFEMUR GLADIATOR HA HIP STEM
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Applicant Contact matt paul
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Correspodent Contact matt paul
Regulation Number 888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDL   LZO  
Date Received 07/27/2011
Decision Date 11/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No