The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Itotal Cr Knee Replacement System.
| Device ID | K094050 |
| 510k Number | K094050 |
| Device Name: | ITOTAL CR KNEE REPLACEMENT SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | CONFORMIS, INC. 2 FOURTH AVENUE Burlington, MA 01803 |
| Contact | Amita S Shah |
| Correspondent | Amita S Shah 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 | 2009-12-31 |
| Decision Date | 2010-09-16 |
| Summary: | summary |