The following data is part of a premarket notification filed by Conformis Inc. with the FDA for Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (ps) Krs And Identity Imprint Cruciate Retaining (cr) Krs).
| Device ID | K212411 |
| 510k Number | K212411 |
| Device Name: | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS And Identity Imprint Cruciate Retaining (CR) KRS) |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Conformis Inc. 600 Technology Park Drive, 4th Floor Billerica, MA 01821 |
| Contact | Kara Johnson |
| Correspondent | Kara Johnson Conformis Inc. 600 Technology Park Drive, 4th 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-03 |
| Decision Date | 2021-09-23 |