EXETER HIP STEM


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, cemented

510(k) Number K110290
Device Name EXETER HIP STEM
Applicant
HOWMEDICA OSTEONICS CORP
325 corporate dr.
mahwah, 
NJ 
07430

Applicant Contact valerie giambanco
Correspondent
HOWMEDICA OSTEONICS CORP
325 corporate dr.
mahwah, 
NJ 
07430

Correspodent Contact valerie giambanco
Regulation Number 888.3350
Classification Product Code
JDI  
Date Received 02/01/2011
Decision Date 09/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No