BIPOLAR SHOULDER PROSTHESIS


Device Classification Name

prosthesis, shoulder, non-constrained, metal/polymer cemented

510(k) Number K991585
Device Name BIPOLAR SHOULDER PROSTHESIS
Applicant
BIOMET, INC.
airport industrial park,
p.o.box 587
warsaw, 
IN 
46581 -0587

Applicant Contact fred mcclure
Correspondent
BIOMET, INC.
airport industrial park,
p.o.box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact fred mcclure
Regulation Number 888.3650
Classification Product Code
KWT  
Subsequent Product Code
MJT  
Date Received 05/07/1999
Decision Date 08/18/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No