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 | K153721 |
| 510k Number | K153721 |
| 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 Shah |
| Correspondent | Amita Shah CONFORMIS, INC. 28 Crosby Dr. Bedford, MA 01730 |
| Product Code | JWH |
| Subsequent Product Code | OIY |
| Subsequent Product Code | OOG |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-28 |
| Decision Date | 2016-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M572RCR0201600131 | K153721 | 000 |
| M572RCR020000I131 | K153721 | 000 |
| M572RCR020000G131 | K153721 | 000 |
| M572RCR020000F131 | K153721 | 000 |
| M572RCR020000E131 | K153721 | 000 |
| M572RCR020000D131 | K153721 | 000 |
| M572RCR020000B131 | K153721 | 000 |
| M572RCR020000A131 | K153721 | 000 |
| M572RCR020000H131 | K153721 | 000 |
| M572RCR020000K131 | K153721 | 000 |
| M572RCR0200600131 | K153721 | 000 |
| M572RCR0201500131 | K153721 | 000 |
| M572RCR0201400131 | K153721 | 000 |
| M572RCR0201300131 | K153721 | 000 |
| M572RCR0201200131 | K153721 | 000 |
| M572RCR0201100131 | K153721 | 000 |
| M572RCR0201000131 | K153721 | 000 |
| M572RCR0200900131 | K153721 | 000 |
| M572RCR0200800131 | K153721 | 000 |
| M572RCR020000J131 | K153721 | 000 |