Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K031826 |
Device Name |
TRIHA + |
Applicant |
TEKNIMED SA |
1001 OAKWOOD BLVD |
ROUNDROCK,
TX
78681
|
|
Applicant Contact |
J. D WEBB |
Correspondent |
TEKNIMED SA |
1001 OAKWOOD BLVD |
ROUNDROCK,
TX
78681
|
|
Correspondent Contact |
J. D WEBB |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 06/13/2003 |
Decision Date | 11/28/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|