Device Classification Name cement, bone, vertebroplasty
510(k) Number K100404
Device Name ASCENDX VCF REDUCTION SYSTEM
Applicant
AOI MEDICAL, INC.
1835 MARKET STREET
29TH FLOOR
PHILADELPHIA,  PA  19103
Applicant Contact JANICE M HOGAN
Correspondent
AOI MEDICAL, INC.
1835 MARKET STREET
29TH FLOOR
PHILADELPHIA,  PA  19103
Correspondent Contact JANICE M HOGAN
Regulation Number888.3027
Classification Product Code
NDN  
Date Received02/16/2010
Decision Date 12/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No