REPIPHYSIS LIMB SALVAGE SYSTEM


Device Classification Name

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

510(k) Number K021489
Device Name REPIPHYSIS LIMB SALVAGE SYSTEM
Original Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Original Contact ehab m esmail
Regulation Number 888.3510
Classification Product Code
KRO  
Date Received 05/08/2002
Decision Date 12/04/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No