TDM Screw Systems— 510(k) K190830
Substantially EquivalentTdm Co., Ltd.
FDA 510(k) clearance K190830 for TDM Screw Systems, Substantially Equivalent on 2019-09-13. Applicant: Tdm Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Tdm Co., Ltd.
- Product code
- Product code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gwangju, KR
Recent devices under product code HWC
view allMore clearances from Tdm Co., Ltd.
view all- K263269 — Park's Pectus System
- K261611 — TDM Large Bone Plate and Screw System
- K263062 — NOVIX Pedicle 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
Adverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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.