K221792 is an FDA 510(k) clearance for the Acute QC Strut and Components. This device is classified as a Software For Diagnosis/treatment (Class II - Special Controls, product code OSN).
Submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on August 25, 2022, 65 days after receiving the submission on June 21, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030. Software Associated With An Orthopedic Trauma Device Which Is Intended For The Diagnosis Or Treatment Of Traumatic Or Reconstructive Orthopedic Conditions.
| 510(k) Number | K221792 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2022 |
| Decision Date | August 25, 2022 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OSN — Software For Diagnosis/treatment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
| Definition | Software Associated With An Orthopedic Trauma Device Which Is Intended For The Diagnosis Or Treatment Of Traumatic Or Reconstructive Orthopedic Conditions |