# Eden Spine, LLC

- Location (FDA's records): Apple Valley, MN
- FDA decisions: 2 (2012–2016): 2 510(k) clearances
- Product codes: MQP (1), KWQ (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 1 (0 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
- Osteotech, Inc.: 1 (https://510kreport.com/company/osteotech)
- Ulrich GmbH & Co. KG: 1 (https://510kreport.com/company/ulrich)
- Sofamor Danek Mfg., Inc.: 1 (https://510kreport.com/company/sofamor-danek-mfg)
- Smith & Nephew, Inc., Orthopaedic Div.: 1 (https://510kreport.com/company/smith-nephew-orthopaedic-div)

## Firms that cite its devices most
- CarboFix Orthopedics, Ltd.: 1 (https://510kreport.com/company/carbofix-orthopedics)

## Its most-cited devices
- K112429: Giza (R) Vertebral Body Replacement (2012), cited by 1

## Recent decisions
- K160982: Sphynx™ (Dec 22, 2016)
- K112429: Giza (R) Vertebral Body Replacement (Jan 26, 2012)

Source page: https://510kreport.com/company/eden-spine