ENDO HEAD


Device Classification Name

prosthesis, hip, hemi-, femoral, metal ball

510(k) Number K111145
Device Name ENDO HEAD
Applicant
MEDACTA INTERNATIONAL
4725 calle quetzal, unit b
camarillo, 
CA 
93012

Applicant Contact adam gross
Correspondent
MEDACTA INTERNATIONAL
4725 calle quetzal, unit b
camarillo, 
CA 
93012

Correspodent Contact adam gross
Regulation Number 888.3360
Classification Product Code
LZY  
Date Received 04/22/2011
Decision Date 08/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No