Device Classification Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
|
510(k) Number |
K041081 |
Device Name |
FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES |
Applicant |
HAND INNOVATIONS, INC. |
8905 SW 87TH AVE. |
MIAMI,
FL
33176 -2227
|
|
Applicant Contact |
AL WEISENBORN |
Correspondent |
HAND INNOVATIONS, INC. |
8905 SW 87TH AVE. |
MIAMI,
FL
33176 -2227
|
|
Correspondent Contact |
AL WEISENBORN |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 04/26/2004 |
Decision Date | 07/01/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|