ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM


Device Classification Name

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

510(k) Number K023102
Device Name ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
Original Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Original Contact debra bing
Regulation Number 888.3353
Classification Product Code
MEH  
Date Received 09/18/2002
Decision Date 10/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No