Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K920034 |
Device Name |
DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC |
Applicant |
PFIZER HOSPITAL PRODUCTS GROUP, INC. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Applicant Contact |
MARGARET F CROWE |
Correspondent |
PFIZER HOSPITAL PRODUCTS GROUP, INC. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Correspondent Contact |
MARGARET F CROWE |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 01/06/1992 |
Decision Date | 03/18/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|