| Device Classification Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
|
| 510(k) Number |
K033856 |
| Device Name |
5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN |
| Applicant |
| Peter Stevens, MD |
| P.O. Box 58246 |
|
Salt Lake City,
UT
84158
|
|
| Applicant Contact |
PETER STEVENS, MD |
| Correspondent |
| Peter Stevens, MD |
| P.O. Box 58246 |
|
Salt Lake City,
UT
84158
|
|
| Correspondent Contact |
PETER STEVENS, MD |
| Regulation Number | 888.3030 |
| Classification Product Code |
|
| Subsequent Product Code |
|
| Date Received | 12/11/2003 |
| Decision Date | 01/07/2005 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|