Device Classification Name |
Filler, Bone Void, Calcium Compound
|
510(k) Number |
K041493 |
FOIA Releasable 510(k) |
K041493
|
Device Name |
CEMENTEK |
Applicant |
TEKNIMED SA |
1001 OAKWOOD BLVD |
ROUND ROCK,
TX
78681
|
|
Applicant Contact |
J.D. WEBB |
Correspondent |
TEKNIMED SA |
1001 OAKWOOD BLVD |
ROUND ROCK,
TX
78681
|
|
Correspondent Contact |
J.D. WEBB |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 06/04/2004 |
Decision Date | 08/19/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|