K193660 is an FDA 510(k) clearance for the OSSIOfiber™ Compression Screws. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by OSSIO , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on July 30, 2020, 213 days after receiving the submission on December 30, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K193660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2019 |
| Decision Date | July 30, 2020 |
| Days to Decision | 213 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 |