The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Iuni Unicondylar Knee Replacement System, Iduo Bicompartmental Knee Repair System, Itotal Cr Knee Replacement System, Itotal Ps Knee Replacement System.
| Device ID | K193105 |
| 510k Number | K193105 |
| Device Name: | IUni Unicondylar Knee Replacement System, IDuo Bicompartmental Knee Repair System, ITotal CR Knee Replacement System, ITotal PS Knee Replacement System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Conformis, Inc. 600 Technology Park Drive Billerica, MA 01821 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen Conformis, Inc. 600 Technology Park Drive Billerica, MA 01821 |
| Product Code | JWH |
| Subsequent Product Code | HSX |
| Subsequent Product Code | NPJ |
| Subsequent Product Code | OIY |
| Subsequent Product Code | OOG |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-08 |
| Decision Date | 2020-03-13 |