Device Classification Name |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
|
510(k) Number |
K153657 |
Device Name |
Vanguard XP Knee System |
Applicant |
BIOMET, INC. |
56 EAST BELL DRIVE |
WARSAW,
IN
46581
|
|
Applicant Contact |
JULIE GANTENBERG |
Correspondent |
BIOMET, INC. |
56 EAST BELL DRIVE |
WARSAW,
IN
46581
|
|
Correspondent Contact |
JULIE GANTENBERG |
Regulation Number | 888.3565
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/21/2015 |
Decision Date | 05/10/2016 |
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
|
|
|