Device Classification Name |
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
|
510(k) Number |
K143543 |
Device Name |
Prelude PF Patellae |
Applicant |
BIOMET INC. |
56 EAST BELL DRIVE |
WARSAW,
IN
46581
|
|
Applicant Contact |
JARED COOPER |
Correspondent |
BIOMET INC. |
56 EAST BELL DRIVE |
WARSAW,
IN
46581
|
|
Correspondent Contact |
JARED COOPER |
Regulation Number | 888.3540
|
Classification Product Code |
|
Date Received | 12/15/2014 |
Decision Date | 01/30/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|