The following data is part of a premarket notification filed by Conformis Inc. with the FDA for Itotal Posterior Stabilized (ps) Knee Replacement System.
| Device ID | K142404 |
| 510k Number | K142404 |
| Device Name: | ITotal Posterior Stabilized (PS) Knee Replacement System |
| 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 |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-27 |
| Decision Date | 2014-12-11 |
| Summary: | summary |