Device Classification Name |
plate, bone
|
510(k) Number |
K973145 |
Device Name |
TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM |
Applicant |
SOFAMOR DANEK USA,INC. |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Applicant Contact |
RICHARD W TREHARNE |
Correspondent |
SOFAMOR DANEK USA,INC. |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Correspondent Contact |
RICHARD W TREHARNE |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 08/22/1997 |
Decision Date | 11/19/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|