TDM Large Bone Plate and Screw System— 510(k) K232115
Substantially EquivalentTdm Co., Ltd.
FDA 510(k) clearance K232115 for TDM Large Bone Plate and Screw System, Substantially Equivalent on 2024-04-05. Applicant: Tdm Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Tdm Co., Ltd.
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gwangju, KR
Recent devices under product code HRS
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
- K240423 — TDM Anterior Cervical Plate System
- K231860 — TDM Screw System
- K221844 — TDM Lumbar Interbody Fusion Cage System
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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.