Suzhou Endophix Co., Ltd. · Class II · Cleared Jun 7, 2023
| K-number | K231002 |
| Device name | Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) |
| Applicant | Suzhou Endophix Co., Ltd. |
| Product code | MBI |
| Device class | Class II |
| Decision date | Jun 7, 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