Device Classification Name |
pin, fixation, smooth
|
510(k) Number |
K153204 |
Device Name |
In2Bones Kirschner wire |
Applicant |
IN2BONES SAS |
28 CHEMIN DU PETIT BOIS |
ECULLY,
FR
69130
|
|
Applicant Contact |
Morgane Grenier |
Correspondent |
Estrin Consulting Group LLC |
9109 Copenhaver Drive |
Potomac,
MD
20854
|
|
Correspondent Contact |
Norman F Estrin |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/04/2015 |
Decision Date | 02/01/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|