The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Confidence High Viscosity Spinal Cement, 16g / 20g.
| Device ID | K112907 |
| 510k Number | K112907 |
| Device Name: | CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 |
| Contact | Robin Dinardo |
| Correspondent | Robin Dinardo MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-03 |
| Decision Date | 2011-12-22 |
| Summary: | summary |