Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K052687 |
Device Name |
CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM |
Applicant |
CONFORMIS, INC. |
323 VINTAGE PARK DR. |
SUITE C |
FOSTER CITY,
CA
94404
|
|
Applicant Contact |
PATRICK HESS |
Correspondent |
CONFORMIS, INC. |
323 VINTAGE PARK DR. |
SUITE C |
FOSTER CITY,
CA
94404
|
|
Correspondent Contact |
PATRICK HESS |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 09/28/2005 |
Decision Date | 08/31/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|