Device Classification Name |
pin, fixation, smooth
|
510(k) Number |
K173051 |
Device Name |
Orthofix MJ-FLEX THE NEW METAIZEAU NAIL |
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 |
Chery Wagoner |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/28/2017 |
Decision Date | 11/16/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|