Device Classification Name |
Screw, Fixation, Intraosseous
|
510(k) Number |
K993493 |
Device Name |
THE AUTOTAC SYSTEM |
Applicant |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
ONE PERIMETER PARK SOUTH |
SUITE 230, SOUTH |
BIRMINGHAM,
AL
35243
|
|
Applicant Contact |
WINSTON D GREER |
Correspondent |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
ONE PERIMETER PARK SOUTH |
SUITE 230, SOUTH |
BIRMINGHAM,
AL
35243
|
|
Correspondent Contact |
WINSTON D GREER |
Regulation Number | 872.4880
|
Classification Product Code |
|
Date Received | 10/15/1999 |
Decision Date | 01/07/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|