K193491 is an FDA 510(k) clearance for the restor3d Metallic Interference Screw. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Restor3d (Durham, US). The FDA issued a Cleared decision on March 19, 2020, 93 days after receiving the submission on December 17, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K193491 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2019 |
| Decision Date | March 19, 2020 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| 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 |