Device Classification Name |
prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
|
510(k) Number |
K061011 |
Device Name |
COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE |
Applicant |
SMITH & NEPHEW, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Applicant Contact |
GINO ROUSS |
Correspondent |
SMITH & NEPHEW, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Correspondent Contact |
GINO ROUSS |
Regulation Number | 888.3520
|
Classification Product Code |
|
Date Received | 04/12/2006 |
Decision Date | 07/11/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|