Device Classification Name |
prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
|
510(k) Number |
K072368 |
Device Name |
CONFORMIS METAL BACKED TIBIAL COMPONENT |
Applicant |
CONFORMIS, INC. |
2 FOURTH AVENUE |
burlington,
MA
01803
|
|
Applicant Contact |
michael sharp |
Correspondent |
CONFORMIS, INC. |
2 FOURTH AVENUE |
burlington,
MA
01803
|
|
Correspondent Contact |
michael sharp |
Regulation Number | 888.3520
|
Classification Product Code |
|
Date Received | 08/23/2007 |
Decision Date | 09/20/2007 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|