Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K210252 |
Device Name |
iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System |
Applicant |
Conformis Inc. |
600 Technology Park Drive, 4th Floor |
Billerica,
MA
01821
|
|
Applicant Contact |
Mary Kruitwagen |
Correspondent |
Conformis Inc. |
600 Technology Park Drive, 4th Floor |
Billerica,
MA
01821
|
|
Correspondent Contact |
Mary Kruitwagen |
Regulation Number | 888.3560
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/29/2021 |
Decision Date | 02/17/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|