Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K112780 |
Device Name |
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
Applicant |
CONFORMIS, INC. |
11 NORTH AVENUE |
BURLINGTON,
MA
01803
|
|
Applicant Contact |
AMITA S SHAH |
Correspondent |
CONFORMIS, INC. |
11 NORTH AVENUE |
BURLINGTON,
MA
01803
|
|
Correspondent Contact |
AMITA S SHAH |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 09/26/2011 |
Decision Date | 12/15/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|