Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K131337 |
FOIA Releasable 510(k) |
K131337
|
Device Name |
BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA |
Applicant |
ORTHO DEVELOPMENT CORP. |
12187 SOUTH BUSINESS PARK DR. |
DRAPER,
UT
84020
|
|
Applicant Contact |
TOM HAUETER |
Correspondent |
ORTHO DEVELOPMENT CORP. |
12187 SOUTH BUSINESS PARK DR. |
DRAPER,
UT
84020
|
|
Correspondent Contact |
TOM HAUETER |
Regulation Number | 888.3560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/09/2013 |
Decision Date | 10/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|