K221333 is an FDA 510(k) clearance for the Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on December 29, 2022, 234 days after receiving the submission on May 9, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K221333 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2022 |
| Decision Date | December 29, 2022 |
| Days to Decision | 234 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 |