Device Classification Name |
Filler, Bone Void, Calcium Compound
|
510(k) Number |
K030554 |
FOIA Releasable 510(k) |
K030554
|
Device Name |
CALLOS |
Applicant |
SKELETAL KINETICS, LLC |
555 13TH ST. N.W. |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
HOWARD HOLSTEIN |
Correspondent |
SKELETAL KINETICS, LLC |
555 13TH ST. N.W. |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
HOWARD HOLSTEIN |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 02/21/2003 |
Decision Date | 05/20/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|