The following data is part of a premarket notification filed by Tecres Spa with the FDA for Kit Mendec Spine And Delivery System.
| Device ID | K062452 |
| 510k Number | K062452 |
| Device Name: | KIT MENDEC SPINE AND DELIVERY SYSTEM |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | TECRES SPA 1700 RESEARCH BOULEVARD SUITE 220 Rockville, MD 20850 |
| Contact | Christine Brauer |
| Correspondent | Christine Brauer TECRES SPA 1700 RESEARCH BOULEVARD SUITE 220 Rockville, MD 20850 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-22 |
| Decision Date | 2006-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28031497000521 | K062452 | 000 |