MECTACER BIOLOX FORTE-FEMORAL HEADS


Device Classification Name

prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

510(k) Number K073337
Device Name MECTACER BIOLOX FORTE-FEMORAL HEADS
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 888.3353
Classification Product Code
LZO  
Date Received 11/28/2007
Decision Date 02/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No