Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K002775 |
Device Name |
DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM |
Applicant |
HAND INNOVATIONS, INC. |
19526 EAST LAKE DR. |
MIAMI,
FL
33015
|
|
Applicant Contact |
AL WEISENBORN |
Correspondent |
HAND INNOVATIONS, INC. |
19526 EAST LAKE DR. |
MIAMI,
FL
33015
|
|
Correspondent Contact |
AL WEISENBORN |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 09/06/2000 |
Decision Date | 12/05/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|