Device Classification Name |
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
|
510(k) Number |
K073329 |
Device Name |
SYGNAL DBM |
Applicant |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
125 MAY STREET |
EDISON,
NJ
08837
|
|
Applicant Contact |
NANCY BENNEWITZ |
Correspondent |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
125 MAY STREET |
EDISON,
NJ
08837
|
|
Correspondent Contact |
NANCY BENNEWITZ |
Regulation Number | 888.3045
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/27/2007 |
Decision Date | 02/28/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|