REJUVENATE MODULAR HIP SYSTEM


Device Classification Name

prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

510(k) Number K081044
Device Name REJUVENATE MODULAR HIP SYSTEM
Applicant
HOWMEDICA OSTEONICS CORP
325 corporate dr.
mahwah, 
NJ 
07430

Applicant Contact denise daugert
Correspondent
HOWMEDICA OSTEONICS CORP
325 corporate dr.
mahwah, 
NJ 
07430

Correspodent Contact denise daugert
Regulation Number 888.3353
Classification Product Code
MEH  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LPH  
LWJ   LZO  
Date Received 04/14/2008
Decision Date 06/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No