Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K010322 |
Device Name |
ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) |
Applicant |
ORTHODYNE, INC. |
1118 SO. ORANGE AVE. |
SUITE 204 |
ORLANDO,
FL
32806
|
|
Applicant Contact |
CARL KNOBLOCH |
Correspondent |
ORTHODYNE, INC. |
1118 SO. ORANGE AVE. |
SUITE 204 |
ORLANDO,
FL
32806
|
|
Correspondent Contact |
CARL KNOBLOCH |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 02/02/2001 |
Decision Date | 05/02/2001 |
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
|
|
|