The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Unicondylar Knee Repair System / Conformis Ucd.
| Device ID | K043570 |
| 510k Number | K043570 |
| Device Name: | UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | CONFORMIS, INC. 323 VINTAGE PARK DR. SUITE C Foster City, CA 94404 |
| Contact | Lyndall Erb |
| Correspondent | Lyndall Erb CONFORMIS, INC. 323 VINTAGE PARK DR. SUITE C Foster City, CA 94404 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-27 |
| Decision Date | 2005-03-14 |
| Summary: | summary |