K781389 is an FDA 510(k) clearance for the BIOMET CONCENTRIC HEX SCREW. This device is classified as a Device, Fixation, Proximal Femoral, Implant (Class II - Special Controls, product code JDO).
Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 21, 1978, 11 days after receiving the submission on August 10, 1978.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K781389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1978 |
| Decision Date | August 21, 1978 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDO — Device, Fixation, Proximal Femoral, Implant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |