Device Classification Name |
Filler, Bone Void, Calcium Compound
|
510(k) Number |
K100986 |
Device Name |
CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION |
Applicant |
SKELETAL KINETICS, LLC |
10201 BUBB RD. |
CUPERTINO,
CA
95014 -4167
|
|
Applicant Contact |
CHRISTINE KUO |
Correspondent |
SKELETAL KINETICS, LLC |
10201 BUBB RD. |
CUPERTINO,
CA
95014 -4167
|
|
Correspondent Contact |
CHRISTINE KUO |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 04/09/2010 |
Decision Date | 07/20/2010 |
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
|
|
|