Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K081510 |
Device Name |
TIGER CANNULATED SCREW SYSTEM |
Applicant |
TRILLIANT SURGICAL LTD |
1001 OAKWOOD BLVD |
ROUND ROCK,
TX
78681
|
|
Applicant Contact |
J. D WEBB |
Correspondent |
TRILLIANT SURGICAL LTD |
1001 OAKWOOD BLVD |
ROUND ROCK,
TX
78681
|
|
Correspondent Contact |
J. D WEBB |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 05/29/2008 |
Decision Date | 08/04/2008 |
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
|
|
|