K080873 is an FDA 510(k) clearance for the OPACITY + BONE CEMENT. This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by Teknimed, S.A. (Round Rock, US). The FDA issued a Cleared decision on August 28, 2008, 150 days after receiving the submission on March 31, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K080873 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2008 |
| Decision Date | August 28, 2008 |
| Days to Decision | 150 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NDN — Cement, Bone, Vertebroplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |