Device Classification Name |
prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
|
510(k) Number |
K150680 |
Device Name |
Freedom Cementless Femoral Component |
Applicant |
MAXX ORTHOPEDICS, INC. |
531 PLYMOUTH RD., SUITE 526 |
PLYMOUTH MEETING,
PA
19462
|
|
Applicant Contact |
Gabriela Gottlieb |
Correspondent |
MAXX ORTHOPEDICS, INC. |
531 PLYMOUTH RD., SUITE 526 |
PLYMOUTH MEETING,
PA
19462
|
|
Correspondent Contact |
Gabriela Gottlieb |
Regulation Number | 888.3565
|
Classification Product Code |
|
Date Received | 03/17/2015 |
Decision Date | 06/26/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|