Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K033756 |
Device Name |
VOLAR RADIUS PLATE WITH ANGULAR STABILITY |
Applicant |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
3150 E. 200TH ST. |
PRIOR LAKE,
MN
55372
|
|
Applicant Contact |
AL LIPPINCOTT |
Correspondent |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
3150 E. 200TH ST. |
PRIOR LAKE,
MN
55372
|
|
Correspondent Contact |
AL LIPPINCOTT |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 12/01/2003 |
Decision Date | 02/06/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|