ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM


Device Classification Name

prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

510(k) Number K030373
Device Name ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM
Applicant
CENTERPULSE ORTHOPEDICS, INC.
9900 spectrum dr.
austin, 
TX 
78717

Applicant Contact audrey swearingen
Correspondent
CENTERPULSE ORTHOPEDICS, INC.
9900 spectrum dr.
austin, 
TX 
78717

Correspodent Contact audrey swearingen
Regulation Number 888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   KWL   KWY  
Date Received 02/04/2003
Decision Date 03/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls