Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K040262 |
Device Name |
DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX |
Applicant |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
125 MAY ST |
EDISON,
NJ
08837
|
|
Applicant Contact |
KATHLEEN M LAFFAN |
Correspondent |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
125 MAY ST |
EDISON,
NJ
08837
|
|
Correspondent Contact |
KATHLEEN M LAFFAN |
Regulation Number | 888.3045
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/04/2004 |
Decision Date | 03/17/2005 |
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
|
|
|