Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K031219 |
Device Name |
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) |
Applicant |
ORTHOFIX, INC. |
1720 BRAY CENTRAL DR. |
MCKINNEY,
TX
75069
|
|
Applicant Contact |
MARY BIGGERS |
Correspondent |
ORTHOFIX, INC. |
1720 BRAY CENTRAL DR. |
MCKINNEY,
TX
75069
|
|
Correspondent Contact |
MARY BIGGERS |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 04/17/2003 |
Decision Date | 05/28/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|