K202589 is an FDA 510(k) clearance for the APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Medartis AG (Basel, CH). The FDA issued a Cleared decision on November 6, 2020, 59 days after receiving the submission on September 8, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K202589 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2020 |
| Decision Date | November 06, 2020 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | HWC — Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |