The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Iuni Unicondylar Knee Replacement System.
| Device ID | K132640 |
| 510k Number | K132640 |
| Device Name: | IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, 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 | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-23 |
| Decision Date | 2013-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M572UKA1111111011 | K132640 | 000 |