BIO-MODULAR SHOULDER SYSTEM


Device Classification Name

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

510(k) Number K030710
Device Name BIO-MODULAR SHOULDER SYSTEM
Applicant
BIOMET, INC.
56 bell dr.
po box 587
warsaw, 
IN 
46581 -0587

Applicant Contact patricia sandborn beres
Correspondent
BIOMET, INC.
56 bell dr.
po box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact patricia sandborn beres
Regulation Number 888.3650
Classification Product Code
KWT  
Subsequent Product Codes
HSD   KWS   MBF  
Date Received 03/06/2003
Decision Date 06/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls