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 Number | 888.3027
|
Classification Product Code |
|
Date Received | 02/16/2010 |
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
|