BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM


Device Classification Name

cerclage, fixation

510(k) Number K110039
Device Name BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
Applicant
BIOMET SPORTS MEDICINE
56 east bell drive
p.o. box 587
warsaw, 
IN 
46581 -0587

Applicant Contact elizabeth wray
Correspondent
BIOMET SPORTS MEDICINE
56 east bell drive
p.o. box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact elizabeth wray
Regulation Number 888.3010
Classification Product Code
JDQ  
Date Received 01/06/2011
Decision Date 05/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No