Device Classification Name |
prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
|
510(k) Number |
K061223 |
Device Name |
ADVANCE TOTAL KNEE SYSTEM |
Applicant |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. |
ARLINGTON,
TN
38002
|
|
Applicant Contact |
THERESA LEISTER |
Correspondent |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. |
ARLINGTON,
TN
38002
|
|
Correspondent Contact |
THERESA LEISTER |
Regulation Number | 888.3565
|
Classification Product Code |
|
Date Received | 05/02/2006 |
Decision Date | 08/18/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|