# Medical Designs, LLC

- Location (FDA's records): Sioux Falls, SD
- FDA decisions: 7 (2000–2018): 7 510(k) clearances
- Product codes: MAX (3), JXG (2), PEK (1), KWQ (1)
- Predicates its devices cite: 18 (4 its own); citations of its devices by later devices: 10 (4 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Stryker Spine: 2 (https://510kreport.com/company/stryker-spine)
- Ldr Spine USA: 2 (https://510kreport.com/company/ldr-spine-usa)
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Pudenz-Schulte Medical Research Corp.: 1 (https://510kreport.com/company/pudenz-schulte-medical-research)
- Renovis Surgical Technologies, LLC: 1 (https://510kreport.com/company/renovis-surgical-technologies)
- Centinel Spine, Inc.: 1 (https://510kreport.com/company/centinel-spine)
- Depuy Spine, Inc.: 1 (https://510kreport.com/company/depuy-spine)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)

## Firms that cite its devices most
- Life Spine, Inc.: 2 (https://510kreport.com/company/life-spine)
- Alphatec Spine, Inc.: 1 (https://510kreport.com/company/alphatec-spine)
- Wenzel Spine, Inc.: 1 (https://510kreport.com/company/wenzel-spine)
- Phasor Health, LLC: 1 (https://510kreport.com/company/phasor-health)
- Borvo Medical, Inc.: 1 (https://510kreport.com/company/borvo-medical)

## Its most-cited devices
- K090048: Asfora Bullet Cage System (2009), cited by 4
- K112648: Asfora Bullet Cage (2012), cited by 3
- K042359: Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal), (Seps-Cand),Models 11-0401 CA, 11-0401-Cal (2004), cited by 2
- K002970: Subdural Evacuating Port System, Model 11-9901 (2000), cited by 1

## Recent decisions
- K182352: SP-LINK™ System (Nov 21, 2018)
- K181591: Fixated Asfora BULLET CAGE® (FABC) (Sep 26, 2018)
- K143688: Asfora Anterior Cervical Plate System (Jul 1, 2015)
- K112648: Asfora Bullet Cage (Mar 13, 2012)
- K090048: Asfora Bullet Cage System (Aug 14, 2009)
- K042359: Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal), (Seps-Cand),Models 11-0401 CA, 11-0401-Cal (Nov 17, 2004)
- K002970: Subdural Evacuating Port System, Model 11-9901 (Dec 12, 2000)

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