REUNITE SCREWS


Device Classification Name

screw, fixation, bone

510(k) Number K992301
Device Name REUNITE SCREWS
Applicant
BIOMET MANUFACTURING, INC.
airport industrial park
p.o. box 587
warsaw, 
IN 
46581 -0587

Applicant Contact michelle l mckinley
Correspondent
BIOMET MANUFACTURING, INC.
airport industrial park
p.o. box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact michelle l mckinley
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received 07/08/1999
Decision Date 09/01/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No