Device Classification Name |
prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
|
510(k) Number |
K912735 |
Device Name |
GENESIS UNICOMPARTMENTAL KNEE SYSTEM |
Applicant |
SMITH & NEPHEW RICHARDS, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Applicant Contact |
ROBERT F GAMES |
Correspondent |
SMITH & NEPHEW RICHARDS, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Correspondent Contact |
ROBERT F GAMES |
Regulation Number | 888.3520
|
Classification Product Code |
|
Date Received | 06/20/1991 |
Decision Date | 12/27/1991 |
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
|
Recalls |
CDRH Recalls
|
|
|