Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K122239 |
Device Name |
FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING |
Applicant |
ENCORE MEDICAL, L.P. |
9800 METRIC BLVD. |
AUSTIN,
TX
78758
|
|
Applicant Contact |
TEFFANY HUTTO |
Correspondent |
ENCORE MEDICAL, L.P. |
9800 METRIC BLVD. |
AUSTIN,
TX
78758
|
|
Correspondent Contact |
TEFFANY HUTTO |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 07/27/2012 |
Decision Date | 04/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|