MEDACTA TOTAL HIP PROSTHESIS SYSTEM – LINE EXTENSION


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, cemented

510(k) Number K080885
Device Name MEDACTA TOTAL HIP PROSTHESIS SYSTEM – LINE EXTENSION
Applicant
MEDACTA INTERNATIONAL, SA
13721 via tres vista
san diego, 
CA 
92129

Applicant Contact natalie j kennel
Correspondent
MEDACTA INTERNATIONAL, SA
13721 via tres vista
san diego, 
CA 
92129

Correspodent Contact natalie j kennel
Regulation Number 888.3350
Classification Product Code
JDI  
Date Received 03/31/2008
Decision Date 04/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No