Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K171054 |
Device Name |
Biomet Knee Joint Replacement Prostheses |
Applicant |
Biomet, Inc |
56 East Bell Drive |
Warsaw,
IN
46581
|
|
Applicant Contact |
Jason Heckaman |
Correspondent |
Biomet, Inc |
56 East Bell Drive |
Warsaw,
IN
46581
|
|
Correspondent Contact |
Jason Heckaman |
Regulation Number | 888.3560 |
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/10/2017 |
Decision Date | 07/28/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
Recalls |
CDRH Recalls
|
|
|