MPACT ACETABULAR SYSTEM


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

510(k) Number K103721
Device Name MPACT ACETABULAR SYSTEM
Applicant
MEDACTA INTERNATIONAL
13721 via tres vista
san diego, 
CA 
92129

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

Correspodent Contact natalie j kennel
Regulation Number 888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received 12/21/2010
Decision Date 03/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No