GUARDIAN INFLATABLE BONE EXPANDER SYSTEM


Device Classification Name

cement, bone, vertebroplasty

510(k) Number K111593
Device Name GUARDIAN INFLATABLE BONE EXPANDER SYSTEM
Applicant
BM KOREA CO., LTD.
1733 canton lane
marietta, 
GA 
30062 -2670

Applicant Contact ronald d arkin
Correspondent
BM KOREA CO., LTD.
1733 canton lane
marietta, 
GA 
30062 -2670

Correspodent Contact ronald d arkin
Regulation Number 888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received 06/07/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No