Device Classification Name |
Filler, Bone Void, Calcium Compound
|
510(k) Number |
K062353 |
Device Name |
MOZAIK BONE REGENERATION MATRIX - PUTTY |
Applicant |
INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR. |
PLAINSBORO,
NJ
08536
|
|
Applicant Contact |
DIANA M BORDON |
Correspondent |
INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR. |
PLAINSBORO,
NJ
08536
|
|
Correspondent Contact |
DIANA M BORDON |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 08/11/2006 |
Decision Date | 12/20/2006 |
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
|
|
|