The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Conformis, Inc. Total Knee Repair System.
| Device ID | K052687 |
| 510k Number | K052687 |
| Device Name: | CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | CONFORMIS, INC. 323 VINTAGE PARK DR. SUITE C Foster City, CA 94404 |
| Contact | Patrick Hess |
| Correspondent | Patrick Hess CONFORMIS, INC. 323 VINTAGE PARK DR. SUITE C Foster City, CA 94404 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-28 |
| Decision Date | 2006-08-31 |
| Summary: | summary |