The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Conformis Itotal(r) Posterior Stabilized (ps) Knee Replacement System (itotal Ps).
| Device ID | K161668 |
| 510k Number | K161668 |
| Device Name: | ConforMIS ITotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) |
| 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 | 2016-06-16 |
| Decision Date | 2016-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850268007484 | K161668 | 000 |
| 00850268007477 | K161668 | 000 |
| 00850268007460 | K161668 | 000 |