Device Classification Name |
Filler, Bone Void, Calcium Compound
|
510(k) Number |
K042125 |
Device Name |
AFT |
Applicant |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
125 MAY STREET |
EDISON,
NJ
08837
|
|
Applicant Contact |
KAREN HARDWICK |
Correspondent |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
125 MAY STREET |
EDISON,
NJ
08837
|
|
Correspondent Contact |
KAREN HARDWICK |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 08/06/2004 |
Decision Date | 07/28/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|