COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE


Device Classification Name

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

510(k) Number K033506
Device Name COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
Applicant
BIOMET, INC.
p.o. box 587
warsaw, 
IN 
46581 -0587

Applicant Contact tracy j bickel
Correspondent
BIOMET, INC.
p.o. box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact tracy j bickel
Regulation Number 888.3660
Classification Product Code
KWS  
Subsequent Product Code
KWT  
Date Received 11/05/2003
Decision Date 02/02/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized