The following data is part of a premarket notification filed by Tecres S.p.a. with the FDA for Kyphon Vue Bone Cement.
| Device ID | K220131 |
| 510k Number | K220131 |
| Device Name: | KYPHON VuE Bone Cement |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | Tecres S.p.A. via Andrea Doria 6 Sommacampagna, IT 37066 |
| Contact | Massio Grazioli |
| Correspondent | Christine Brauer Brauer Device Consultants, LLC 7 Trail House Court Rockville, MD 20850 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-18 |
| Decision Date | 2022-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08031497002538 | K220131 | 000 |
| 00763000590970 | K220131 | 000 |