Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K170165 |
Device Name |
Osteo-P Bone Graft Substitute |
Applicant |
Molecular Matrix, Inc. |
3410 Industrial Blvd., Suite 103 |
West Sacramento,
CA
95691
|
|
Applicant Contact |
Charles Lee |
Correspondent |
Kapstone Medical |
Po Box 969 |
Leicester,
NC
28748
|
|
Correspondent Contact |
John Kapitan |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 01/19/2017 |
Decision Date | 12/29/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|