Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K915512 |
Device Name |
DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS |
Applicant |
PFIZER HOSPITAL PRODUCTS GROUP, INC. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Applicant Contact |
MARGARET CROWE |
Correspondent |
PFIZER HOSPITAL PRODUCTS GROUP, INC. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Correspondent Contact |
MARGARET CROWE |
Regulation Number | 888.3560 |
Classification Product Code |
|
Date Received | 12/09/1991 |
Decision Date | 08/18/1992 |
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
|
Predetermined Change Control Plan Authorized |
No
|
Recalls |
CDRH Recalls
|
|
|