Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K190388 |
Device Name |
RIVAL View Plating Systems and Reduce Fracture Plating Systems |
Applicant |
Orthofix Srl |
Via delle Nazioni, 9 |
Bussolengo,
IT
37012
|
|
Applicant Contact |
Gianluca Ricadona |
Correspondent |
Wagoner Consulting LLC |
PO Box 15729 |
Wilmington,
NC
24408
|
|
Correspondent Contact |
Cheryl Wagoner |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/19/2019 |
Decision Date | 06/07/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|