Trax Surgical · Class II · Cleared Sep 15, 2023
| K-number | K230946 |
| Device name | Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L |
| Applicant | Trax Surgical |
| Product code | HWC |
| Device class | Class II |
| Decision date | Sep 15, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov