# Medical Design, LLC

- Location (FDA's records): Sioux Falls, SD
- FDA decisions: 3 (2002–2012): 3 510(k) clearances
- Product codes: HBG (1), KWQ (1), HWC (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 6 (0 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): 2 (https://510kreport.com/company/synthes-usa)
- Camino Laboratories, Inc.: 1 (https://510kreport.com/company/camino-laboratories)
- Centerpulse Spine-Tech, Inc.: 1 (https://510kreport.com/company/centerpulse-spine-tech)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)

## Firms that cite its devices most
- Orthofix, Inc.: 1 (https://510kreport.com/company/orthofix)
- Osseus Fusion Systems, LLC: 1 (https://510kreport.com/company/osseus-fusion-systems)
- Spinus International, Inc.: 1 (https://510kreport.com/company/spinus-international)
- Zavation Medical Products, LLC: 1 (https://510kreport.com/company/zavation-medical-products)
- Vascular Control Systems, Inc.: 1 (https://510kreport.com/company/vascular-control-systems)
- Medical Designs, LLC: 1 (https://510kreport.com/company/medical-designs)

## Its most-cited devices
- K121148: Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM Dia., 35MM Long, Samba Screw, 9MM D (2012), cited by 4
- K022712: Hand Drill, Model 11-9901-7 (2002), cited by 1
- K122497: Asfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior Cervical Plate System, One Level, 16MM (2012), cited by 1

## Recent decisions
- K122497: Asfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior Cervical Plate System, One Level, 16MM (Oct 15, 2012)
- K121148: Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM Dia., 35MM Long, Samba Screw, 9MM D (Aug 20, 2012)
- K022712: Hand Drill, Model 11-9901-7 (Nov 12, 2002)

Source page: https://510kreport.com/company/medical-design