TDM Anterior Cervical Plate System— 510(k) K240423
Substantially EquivalentTdm Co., Ltd.
FDA 510(k) clearance K240423 for TDM Anterior Cervical Plate System, Substantially Equivalent on 2024-04-08. Applicant: Tdm Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Tdm Co., Ltd.
- Product code
- Code KWQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gwangju, KR
Recent devices under product code KWQ
view allMore clearances from Tdm Co., Ltd.
view all- 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
- K232115 — TDM Large Bone Plate and Screw System
- K231860 — TDM Screw System
- K221844 — TDM Lumbar Interbody Fusion Cage System
Adverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
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.