Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K172583 |
Device Name |
OrthoPediatrics PediNail Intramedullary Platform |
Applicant |
OrthoPediatrics, Inc. |
2850 Frontier Drive |
Warsaw,
IN
46582
|
|
Applicant Contact |
Adam Cargill |
Correspondent |
OrthoPediatrics, Inc. |
2850 Frontier Drive |
Warsaw,
IN
46582
|
|
Correspondent Contact |
James L. Crumley |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 08/28/2017 |
Decision Date | 05/10/2018 |
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
|
|
|