AFFIRM (TM) VCF SYSTEM


Device Classification Name

cement, bone, vertebroplasty

510(k) Number K110998
Device Name AFFIRM (TM) VCF SYSTEM
Applicant
ALGEA THERAPIES
2560 general armistead avenue
audubon, 
PA 
19403

Applicant Contact kelly j baker
Correspondent
ALGEA THERAPIES
2560 general armistead avenue
audubon, 
PA 
19403

Correspodent Contact kelly j baker
Regulation Number 888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received 04/11/2011
Decision Date 10/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No