The following data is part of a premarket notification filed by Tecres Spa with the FDA for Interspace Knee Extra-large Size, Interspace Knee Ats.
| Device ID | K181732 |
| 510k Number | K181732 |
| Device Name: | InterSpace Knee Extra-Large Size, InterSpace Knee ATS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Tecres SpA via Andrea Doria 6 Sommacampagna, IT 37066 |
| Contact | Massimo Grazioli |
| Correspondent | Christine Brauer Brauer Device Consultants, LLC 7 Trial House Court Rockville, MD 20850 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2018-07-02 |
| Decision Date | 2019-04-27 |