APEX K1 HIP STEM


Device Classification Name

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

510(k) Number K110947
Device Name APEX K1 HIP STEM
Applicant
OMNILIFE SCIENCE INC.
50 o’connell way
east taunton, 
MA 
02718

Applicant Contact radhika pondicherry
Correspondent
OMNILIFE SCIENCE INC.
50 o’connell way
east taunton, 
MA 
02718

Correspodent Contact radhika pondicherry
Regulation Number 888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWY   LZO  
Date Received 04/04/2011
Decision Date 06/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No