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 | K140423 |
| 510k Number | K140423 |
| 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 | 2014-02-18 |
| Decision Date | 2014-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M572RCR1011113031 | K140423 | 000 |
| M572RCR0200600011 | K140423 | 000 |
| M572RCR020000K011 | K140423 | 000 |
| M572RCR020000J011 | K140423 | 000 |
| M572RCR020000I011 | K140423 | 000 |
| M572RCR020000H011 | K140423 | 000 |
| M572RCR020000G011 | K140423 | 000 |
| M572RCR020000F011 | K140423 | 000 |
| M572RCR020000E011 | K140423 | 000 |
| M572RCR020000D011 | K140423 | 000 |
| M572RCR020000C011 | K140423 | 000 |
| M572RCR020000B011 | K140423 | 000 |
| M572RCR0200700011 | K140423 | 000 |
| M572RCR0200800011 | K140423 | 000 |
| M572RCR0200900011 | K140423 | 000 |
| M572RCR1011112011 | K140423 | 000 |
| M572RCR010000E031 | K140423 | 000 |
| M572TCR1211111011 | K140423 | 000 |
| M572RCR010000D031 | K140423 | 000 |
| M572RCR0201600011 | K140423 | 000 |
| M572RCR0201500011 | K140423 | 000 |
| M572RCR0201400011 | K140423 | 000 |
| M572RCR0201300011 | K140423 | 000 |
| M572RCR0201200011 | K140423 | 000 |
| M572RCR0201100011 | K140423 | 000 |
| M572RCR0201000011 | K140423 | 000 |
| M572RCR020000A011 | K140423 | 000 |