MECTACER BIOLOX(R) DELTA FEMORAL HEADS


Device Classification Name

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

510(k) Number K112115
Device Name MECTACER BIOLOX(R) DELTA FEMORAL HEADS
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 888.3353
Classification Product Code
LZO  
Date Received 07/25/2011
Decision Date 10/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No