The following data is part of a premarket notification filed by Disc-o-tech Medical Technologies, Ltd. with the FDA for Confidence High Viscosity Bone Cement.
| Device ID | K060300 |
| 510k Number | K060300 |
| Device Name: | CONFIDENCE HIGH VISCOSITY BONE CEMENT |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 11 HA'HOSHLIM ST. Herzliya, IL 46724 |
| Contact | Hila Wachsler-avrahami |
| Correspondent | Hila Wachsler-avrahami DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 11 HA'HOSHLIM ST. Herzliya, IL 46724 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-06 |
| Decision Date | 2006-06-21 |
| Summary: | summary |