NOVIX Pedicle Screw System— 510(k) K263062
Substantially EquivalentTdm Co., Ltd.
FDA 510(k) clearance K263062 for NOVIX Pedicle Screw System, Substantially Equivalent on 2026-10-01. Applicant: Tdm Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Tdm Co., Ltd.
- Product code
- Code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Gwangju, KR
Recent devices under product code NKB
view allMore clearances from Tdm Co., Ltd.
view all- K261611 — TDM Large Bone Plate and Screw System
- K241128 — TDM Plate and Screw System
- K230071 — Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System
- K240423 — TDM Anterior Cervical Plate System
- K232115 — TDM Large Bone Plate and Screw System
Adverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.