Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K113409 |
Device Name |
S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL |
Applicant |
HOWMEDICA OSTEONICS CORP. |
325 CORPORATE DR |
MAHWAH,
NJ
07430
|
|
Applicant Contact |
JUMA HOSHINO |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
325 CORPORATE DR |
MAHWAH,
NJ
07430
|
|
Correspondent Contact |
JUMA HOSHINO |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 11/18/2011 |
Decision Date | 02/15/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|