APEX-LNK POLY ACETABULAR CUP LINERS


Device Classification Name

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

510(k) Number K073150
Device Name APEX-LNK POLY ACETABULAR CUP LINERS
Applicant
OMNI LIFE SCIENCE, INC.
175 paramount drive
raynham, 
MA 
02767

Applicant Contact edward j cheal
Correspondent
OMNI LIFE SCIENCE, INC.
175 paramount drive
raynham, 
MA 
02767

Correspodent Contact edward j cheal
Regulation Number 888.3358
Classification Product Code
LPH  
Subsequent Product Codes
LZO   MEH  
Date Received 11/08/2007
Decision Date 02/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No