ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS


Device Classification Name

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

510(k) Number K021878
Device Name ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS
Original Applicant
ESKA AMERICA CORP.
101 riverfront blvd.
bradenton, 
FL 
34205 -8802

Original Contact thomas p monkus
Regulation Number 888.3358
Classification Product Code
LPH  
Date Received 06/07/2002
Decision Date 03/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No