Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K954909 |
Device Name |
PROFIX POSTERIOR-STABILIZED KNEE SYSTEM |
Applicant |
SMITH & NEPHEW RICHARDS, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Applicant Contact |
THOMAS L CRAIG |
Correspondent |
SMITH & NEPHEW RICHARDS, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Correspondent Contact |
THOMAS L CRAIG |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 10/25/1995 |
Decision Date | 01/31/1996 |
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
|
|
|