COMPREHENSIVE HUMERAL FRACTURE SYSTEM


Device Classification Name

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

510(k) Number K023063
Device Name COMPREHENSIVE HUMERAL FRACTURE SYSTEM
Original Applicant
BIOMET ORTHOPEDICS, INC.
p.o. box 587
warsaw, 
IN 
46581 -0587

Original Contact dalene t binkley
Regulation Number 888.3650
Classification Product Code
KWT  
Subsequent Product Codes
HSD   KWS   MBF  
Date Received 09/16/2002
Decision Date 12/13/2002
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