# Novaspine, LLC

- Location (FDA's records): Elmsford, NY
- FDA decisions: 3 (2005–2006): 3 510(k) clearances
- Product codes: JDK (1), OMP (1), BTA (1)
- Predicates its devices cite: 12 (1 its own); citations of its devices by later devices: 6 (1 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
- Medtronic Sofamor Danek: 3 (https://510kreport.com/company/medtronic-sofamor-danek)
- Spinal Concepts, Inc.: 3 (https://510kreport.com/company/spinal-concepts)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Kinetic Concepts, Inc.: 1 (https://510kreport.com/company/kinetic-concepts)
- Blue Sky Medical Group Incorporated: 1 (https://510kreport.com/company/blue-sky-medical-group)
- Precision Medical, Inc.: 1 (https://510kreport.com/company/precision-medical)
- Medela AG: 1 (https://510kreport.com/company/medela)

## Firms that cite its devices most
- Simex Medizintechnik GmbH: 2 (https://510kreport.com/company/simex-medizintechnik)
- Impact Instrumentation, Inc.: 1 (https://510kreport.com/company/impact-instrumentation)
- Suzric Enterprise Co., Ltd.: 1 (https://510kreport.com/company/suzric-enterprise)
- Medica-Rents Co., Ltd.: 1 (https://510kreport.com/company/medica-rents)

## Its most-cited devices
- K062456: Novaspine Powered Suction Pump Pro-1 (2006), cited by 3
- K061133: Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30S (2006), cited by 3

## Recent decisions
- K062456: Novaspine Powered Suction Pump Pro-1 (Oct 16, 2006)
- K061133: Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30S (Jul 11, 2006)
- K051607: Novaspine Cement Restrictor NSCR (Oct 7, 2005)

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