K072127 is an FDA 510(k) clearance for the DOMINATOR. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Biocomposites, Ltd. (Keele, GB). The FDA issued a Cleared decision on August 31, 2007, 29 days after receiving the submission on August 2, 2007.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K072127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2007 |
| Decision Date | August 31, 2007 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC — Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |