K222967 is an FDA 510(k) clearance for the Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Avanti Orthopaedics, Inc. (Wilmington, US). The FDA issued a Cleared decision on November 23, 2022, 57 days after receiving the submission on September 27, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K222967 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2022 |
| Decision Date | November 23, 2022 |
| Days to Decision | 57 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 |