REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR


Device Classification Name

prosthesis, knee, femorotibial, constrained, cemented, metal/polymer

510(k) Number K072367
Device Name REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Applicant Contact ehab m esmail
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Correspodent Contact ehab m esmail
Regulation Number 888.3510
Classification Product Code
KRO  
Subsequent Product Code
JDI  
Date Received 08/23/2007
Decision Date 01/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No