The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Conformis Total Knee Repiar System (itotal) Tibial Component: 6.0 Mm Thickness.
| Device ID | K080936 |
| 510k Number | K080936 |
| Device Name: | CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | CONFORMIS, INC. 2 FOURTH AVENUE Burlington, MA 01803 |
| Contact | S. Michael Sharp |
| Correspondent | S. Michael Sharp CONFORMIS, INC. 2 FOURTH AVENUE Burlington, MA 01803 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-02 |
| Decision Date | 2008-05-12 |
| Summary: | summary |