Fixone Meniscal Repair— 510(k) K233601
Substantially EquivalentAju Pharm Co., Ltd.
FDA 510(k) clearance K233601 for Fixone Meniscal Repair, Substantially Equivalent on 2024-08-02. Applicant: Aju Pharm Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Aju Pharm Co., Ltd.
- Product code
- Code MBI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seongnam, KR
Recent devices under product code MBI
view allMore clearances from Aju Pharm Co., Ltd.
view allAdverse events under product code MBI
product code MBI- Injury
- 3,163
- Malfunction
- 13,006
- Other
- 2
- Total
- 16,171
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K233601
K-number listed on FDA's recall record- Z-1166-2026 — Fixone Hybrid Anchor
- Z-1167-2026 — Fixone Biocomposite Anchor
- Z-1168-2026 — Genesis Screw-In Anchor
- Z-1169-2026 — Genesis Dual Thread Screw-In Anchor
- Z-1170-2026 — Genesis Knotless Anchor
- Z-1171-2026 — Genesis Push-In Suture Anchor
- Z-1172-2026 — AlternatiV+ Max Knotless Anchor
- Z-1173-2026 — AlternatiV+ Screw-In Anchor
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K233601.
Data sourced from openFDA. This site is unofficial and independent of the FDA.