The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Conformis Itotal Cruciate Retaining (cr) Knee Replacement System.
| Device ID | K180906 |
| 510k Number | K180906 |
| Device Name: | Conformis ITotal Cruciate Retaining (CR) Knee Replacement System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Conformis, Inc. 600 Technology Park Drive, 4 Floor Billerica, MA 01821 |
| Contact | Emmanuel Nyakako |
| Correspondent | Emmanuel Nyakako Conformis, Inc. 600 Technology Park Drive, 4 Floor Billerica, MA 01821 |
| Product Code | JWH |
| Subsequent Product Code | OIY |
| Subsequent Product Code | OOG |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-06 |
| Decision Date | 2018-05-16 |
| Summary: | summary |