TRITANIUM ACETABULAR SHELL SYSTEM


Device Classification Name

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

510(k) Number K081171
Device Name TRITANIUM ACETABULAR SHELL SYSTEM
Applicant
HOWMEDICA OSTEONICS CORP
325 corporate dr.
mahwah, 
NJ 
07430

Applicant Contact kimberly lane
Correspondent
HOWMEDICA OSTEONICS CORP
325 corporate dr.
mahwah, 
NJ 
07430

Correspodent Contact kimberly lane
Regulation Number 888.3358
Classification Product Code
LPH  
Date Received 04/24/2008
Decision Date 07/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No