SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM


Device Classification Name

prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

510(k) Number K023743
Device Name SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
Original Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Original Contact janet johnson akil
Regulation Number 888.3390
Classification Product Code
KWY  
Date Received 11/07/2002
Decision Date 01/23/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No