Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K060294 |
Device Name |
DIAPHYSEAL PLATE |
Applicant |
HAND INNOVATIONS, LLC. |
8905 SW 87TH AVENUE, |
SUITE 220 |
MIAMI LAKES,
FL
33176
|
|
Applicant Contact |
ERNESTO HERNANDEZ |
Correspondent |
HAND INNOVATIONS, LLC. |
8905 SW 87TH AVENUE, |
SUITE 220 |
MIAMI LAKES,
FL
33176
|
|
Correspondent Contact |
ERNESTO HERNANDEZ |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 02/06/2006 |
Decision Date | 03/22/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|