# Tdm Co., Ltd.

- Location (FDA's records): Gwangju, KR
- FDA decisions: 14 (2018–2026): 14 510(k) clearances
- Product codes: HRS (7), HWC (2), NKB (2), MAX (1), HSB (1), KWQ (1)
- 510(k) review time since 2016: median 187 days, against 91 for FDA's reviews in the same codes and years (4 of 14 faster)
- Predicates its devices cite: 51 (4 its own); citations of its devices by later devices: 11 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 18 (https://510kreport.com/company/synthes-usa)
- Arthrex, Inc.: 5 (https://510kreport.com/company/arthrex)
- Synthes (USA) Products, LLC: 4 (https://510kreport.com/company/synthes-usa-products)
- Dio Medical Co., Ltd.: 2 (https://510kreport.com/company/dio-medical)
- Auxein Medical Private Limited: 2 (https://510kreport.com/company/auxein-medical-private)
- Walter Lorenz Surgical, Inc.: 1 (https://510kreport.com/company/walter-lorenz-surgical)
- GS Medical Co., Ltd.: 1 (https://510kreport.com/company/gs-medical)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)

## Firms that cite its devices most
- L&K BIOMED Co., Ltd.: 2 (https://510kreport.com/company/l-k-biomed)
- Techfit Digital Surgery, Inc.: 1 (https://510kreport.com/company/techfit-digital-surgery)
- Solco Biomedical Company India Private Limited: 1 (https://510kreport.com/company/solco-biomedical-company-india-private)
- GM Dos Reis Industria e Comercio Ltda.: 1 (https://510kreport.com/company/gm-dos-reis-industria-e-comercio)
- Jeil Medical Corporation: 1 (https://510kreport.com/company/jeil-medical)
- Artfx Medical: 1 (https://510kreport.com/company/artfx-medical)

## Its most-cited devices
- K191057: Park's Pectus System (2020), cited by 4
- K171808: TDM Plate and Screw System (2018), cited by 4
- K221844: TDM Lumbar Interbody Fusion Cage System (2022), cited by 1
- K190391: TDM Plate and Screw Systems (2019), cited by 1
- K190830: TDM Screw Systems (2019), cited by 1

## Recent decisions
- K263269: Park's Pectus System (Oct 15, 2026)
- K261611: TDM Large Bone Plate and Screw System (Oct 2, 2026)
- K263062: NOVIX Pedicle Screw System (Oct 1, 2026)
- K241128: TDM Plate and Screw System (Dec 5, 2024)
- K230071: Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System (Aug 22, 2024)
- K240423: TDM Anterior Cervical Plate System (Apr 8, 2024)
- K232115: TDM Large Bone Plate and Screw System (Apr 5, 2024)
- K231860: TDM Screw System (Jan 18, 2024)

Source page: https://510kreport.com/company/tdm