510(k) K193497 ยท HWC Screw, Fixation, Bone
Fixone Biocomposite Interference Screw
| Applicant | Aju Pharm Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Jan 5, 2021 |
| Received | Dec 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193497
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2026 | Aju Pharm Co., Ltd. Fixone Hybrid Anchor Open, Classified |
MAI | None listed |
| Jan 26, 2026 | Aju Pharm Co., Ltd. Fixone Biocomposite Anchor Open, Classified |
MAI | None listed |
| Jan 26, 2026 | Aju Pharm Co., Ltd. Genesis Screw-In Anchor Open, Classified |
MAI | None listed |
| Jan 26, 2026 | Aju Pharm Co., Ltd. Genesis Dual Thread Screw-In Anchor Open, Classified |
MAI | None listed |
| Jan 26, 2026 | Aju Pharm Co., Ltd. Genesis Knotless Anchor Open, Classified |
MAI | None listed |
| Jan 26, 2026 | Aju Pharm Co., Ltd. Genesis Push-In Suture Anchor Open, Classified |
MAI | None listed |
| Jan 26, 2026 | Aju Pharm Co., Ltd. AlternatiV+ Max Knotless Anchor Open, Classified |
MAI | None listed |
| Jan 26, 2026 | Aju Pharm Co., Ltd. AlternatiV+ Screw-In Anchor Open, Classified |
MAI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.