Device Classification Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
|
510(k) Number |
K031428 |
Device Name |
SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE |
Applicant |
SYNTHES (USA) |
1690 RUSSELL RD. |
PAOLI,
PA
19301
|
|
Applicant Contact |
BONNIE J SMITH |
Correspondent |
SYNTHES (USA) |
1690 RUSSELL RD. |
PAOLI,
PA
19301
|
|
Correspondent Contact |
BONNIE J SMITH |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 05/06/2003 |
Decision Date | 08/08/2003 |
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
|
|
|