The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Confomis Itotal Cruciate Retaining (cr) Knee Replacement System (itotal Cr Krs).
| Device ID | K161366 |
| 510k Number | K161366 |
| Device Name: | ConfoMIS ITotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | CONFORMIS, INC. 28 Crosby Dr. Bedford, MA 01730 |
| Contact | Amita Shah |
| Correspondent | Amita Shah CONFORMIS, INC. 28 Crosby Dr. Bedford, MA 01730 |
| Product Code | JWH |
| Subsequent Product Code | OIY |
| Subsequent Product Code | OOG |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-17 |
| Decision Date | 2016-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850268007453 | K161366 | 000 |
| M572TCR121SPEC021 | K161366 | 000 |