Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K041461 |
Device Name |
KMI DISTAL VOLAR RADIUS PLATE SYSTEM |
Applicant |
KINETIKOS MEDICAL, INC. |
6005 HIDDEN VALLEY RD, STE 180 |
CARLSBAD,
CA
92011
|
|
Applicant Contact |
JOHN G SPAMPINATO |
Correspondent |
KINETIKOS MEDICAL, INC. |
6005 HIDDEN VALLEY RD, STE 180 |
CARLSBAD,
CA
92011
|
|
Correspondent Contact |
JOHN G SPAMPINATO |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 06/02/2004 |
Decision Date | 08/16/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|