The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Itotal Cruciate Retaining (cr) Knee Replacement System.
| Device ID | K120316 |
| 510k Number | K120316 |
| Device Name: | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | CONFORMIS, INC. 28 Crosby Dr Bedford, MA 01730 |
| Contact | Amita S Shah |
| Correspondent | Amita S Shah CONFORMIS, INC. 28 Crosby Dr Bedford, MA 01730 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-01 |
| Decision Date | 2012-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M572RCR1011113021 | K120316 | 000 |
| M572RCR0101600021 | K120316 | 000 |
| M572RCR0100800021 | K120316 | 000 |