PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING


Device Classification Name

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

510(k) Number K992025
Device Name PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING
Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Applicant Contact marybeth naughton
Correspondent
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Correspodent Contact marybeth naughton
Regulation Number 888.3353
Classification Product Code
MEH  
Date Received 06/16/1999
Decision Date 08/13/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No