Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K101281 |
Device Name |
VEGA KNEE SYSTEM |
Applicant |
AESCULAP IMPLANT SYSTEM, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Applicant Contact |
KATHY A RACOSKY |
Correspondent |
AESCULAP IMPLANT SYSTEM, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Correspondent Contact |
KATHY A RACOSKY |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 05/06/2010 |
Decision Date | 07/30/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|