Device Classification Name |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
|
510(k) Number |
K122015 |
Device Name |
DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE |
Applicant |
HOWMEDICA OSTEONICS CORP. |
325 CORPORATE DR |
MAHWAH,
NJ
07430
|
|
Applicant Contact |
CHRISTIE PENCINGER |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
325 CORPORATE DR |
MAHWAH,
NJ
07430
|
|
Correspondent Contact |
CHRISTIE PENCINGER |
Regulation Number | 888.3510
|
Classification Product Code |
|
Date Received | 07/10/2012 |
Decision Date | 02/22/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|