Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K940235 |
Device Name |
ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT |
Applicant |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. |
ARLINGTON,
TN
38002
|
|
Applicant Contact |
JUDY ENGLISH |
Correspondent |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. |
ARLINGTON,
TN
38002
|
|
Correspondent Contact |
JUDY ENGLISH |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 01/18/1994 |
Decision Date | 10/05/1994 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|