Device Classification Name |
Filler, Bone Void, Calcium Compound
|
510(k) Number |
K032130 |
Device Name |
VITOSS-FILLED CARTRIDGE |
Applicant |
ORTHOVITA, INC. |
45 GREAT VALLEY PKWY. |
MALVERN,
PA
19355
|
|
Applicant Contact |
ANDREINA ANGIE IDE |
Correspondent |
ORTHOVITA, INC. |
45 GREAT VALLEY PKWY. |
MALVERN,
PA
19355
|
|
Correspondent Contact |
ANDREINA ANGIE IDE |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 07/11/2003 |
Decision Date | 11/05/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|