The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Conformis Iuni Unicondylar Knee Replacement System.
| Device ID | K121974 |
| 510k Number | K121974 |
| Device Name: | CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | CONFORMIS, INC. 11 NORTH AVENUE Burlington, MA 01803 |
| Contact | Amita S Shah |
| Correspondent | Amita S Shah CONFORMIS, INC. 11 NORTH AVENUE Burlington, MA 01803 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-05 |
| Decision Date | 2012-09-06 |
| Summary: | summary |