Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K190321 |
Device Name |
Pediatric Nailing PlatformFemur |
Applicant |
OrthoPediatrics, Corp. |
2850 Frontier Drive |
Warsaw,
IN
46582
|
|
Applicant Contact |
Jen Gregory |
Correspondent |
OrthoPediatrics, Corp. |
2850 Frontier Drive |
Warsaw,
IN
46582
|
|
Correspondent Contact |
Jen Gregory |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 02/13/2019 |
Decision Date | 10/09/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|