The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Conformis Uni-condylar Knee System.
| Device ID | K072586 |
| 510k Number | K072586 |
| Device Name: | CONFORMIS UNI-CONDYLAR KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | CONFORMIS, INC. 2 FOURTH AVENUE Burlington, MA 01803 |
| Contact | S. Michael Sharp |
| Correspondent | S. Michael Sharp CONFORMIS, INC. 2 FOURTH AVENUE Burlington, MA 01803 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-13 |
| Decision Date | 2007-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M572RUK0101200011 | K072586 | 000 |
| M572RUK0101100011 | K072586 | 000 |
| M572RUK0101000011 | K072586 | 000 |
| M572RUK0100900011 | K072586 | 000 |
| M572RUK0100800011 | K072586 | 000 |
| M572RUK0100700011 | K072586 | 000 |