The following data is part of a premarket notification filed by Tecres Spa with the FDA for Mendec Spine Hv, Mendec Spine Hv System.
| Device ID | K122175 |
| 510k Number | K122175 |
| Device Name: | MENDEC SPINE HV, MENDEC SPINE HV SYSTEM |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | TECRES SPA 7 Trail House Court Rockville, MD 20850 |
| Contact | Christine Brauer, Ph.d. |
| Correspondent | Christine Brauer, Ph.d. TECRES SPA 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 | 2012-07-23 |
| Decision Date | 2013-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28031497001382 | K122175 | 000 |
| 08031497002316 | K122175 | 000 |
| 08031497003313 | K122175 | 000 |
| 08031497003351 | K122175 | 000 |