The following data is part of a premarket notification filed by Tecres Spa with the FDA for Mendec Spine.
| Device ID | K042415 |
| 510k Number | K042415 |
| Device Name: | MENDEC SPINE |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | TECRES SPA ONE DEMOCRACY PLAZA 6701 DEMOCRACY BLVD. STE. 700 Bethesda, MD 20817 |
| Contact | Christine Brauer |
| Correspondent | Christine Brauer TECRES SPA ONE DEMOCRACY PLAZA 6701 DEMOCRACY BLVD. STE. 700 Bethesda, MD 20817 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-07 |
| Decision Date | 2005-06-09 |
| Summary: | summary |