Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K946088 |
Device Name |
GENESIS POSTERIOR STABILIZED (P/S) KNEE SYSTEM |
Applicant |
SMITH & NEPHEW RICHARDS, INC. |
1450 E. BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Applicant Contact |
THOMAS L CRAIG |
Correspondent |
SMITH & NEPHEW RICHARDS, INC. |
1450 E. BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Correspondent Contact |
THOMAS L CRAIG |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 12/13/1994 |
Decision Date | 08/08/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|