Device Classification Name |
Filler, Bone Void, Calcium Compound
|
510(k) Number |
K082615 |
Device Name |
GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES |
Applicant |
OSTEOTECH INC |
51 JAMES WAY |
EATONTOWN,
NJ
07724
|
|
Applicant Contact |
CHRIS TALBOT |
Correspondent |
OSTEOTECH INC |
51 JAMES WAY |
EATONTOWN,
NJ
07724
|
|
Correspondent Contact |
CHRIS TALBOT |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 09/09/2008 |
Decision Date | 10/16/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|