Fixone Biocomposite Interference Screw
FDA 510(k) clearance K193497 · decided 2021-01-05
Clearance details
- K-number
- K193497
- Device name
- Fixone Biocomposite Interference Screw
- Applicant
- Aju Pharm Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-17
- Decision date
- 2021-01-05
- Days to decision
- 385 days
- Clearance type
- Traditional
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Seongnam-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fixone Hybrid Anchor recall (Z-1166-2026) | Aju Pharm Co., Ltd. | 2026-01-26 |
| Fixone Biocomposite Anchor recall (Z-1167-2026) | Aju Pharm Co., Ltd. | 2026-01-26 |
| Genesis Screw-In Anchor recall (Z-1168-2026) | Aju Pharm Co., Ltd. | 2026-01-26 |
| Genesis Dual Thread Screw-In Anchor recall (Z-1169-2026) | Aju Pharm Co., Ltd. | 2026-01-26 |
| Genesis Knotless Anchor recall (Z-1170-2026) | Aju Pharm Co., Ltd. | 2026-01-26 |
| Genesis Push-In Suture Anchor recall (Z-1171-2026) | Aju Pharm Co., Ltd. | 2026-01-26 |
| AlternatiV+ Max Knotless Anchor recall (Z-1172-2026) | Aju Pharm Co., Ltd. | 2026-01-26 |
| AlternatiV+ Screw-In Anchor recall (Z-1173-2026) | Aju Pharm Co., Ltd. | 2026-01-26 |