# Benvenue Medical, Inc.

- Location (FDA's records): Santa Clara, CA
- FDA decisions: 8 (2007–2020): 8 510(k) clearances
- Product codes: MAX (4), NDN (2), OCJ (1), NKB (1)
- 510(k) review time since 2016: median 150 days, against 115 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 21 (5 its own); citations of its devices by later devices: 11 (5 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
- Kyphon, Inc.: 2 (https://510kreport.com/company/kyphon)
- Spinal Elements, Inc.: 2 (https://510kreport.com/company/spinal-elements)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Trans1 Incorporated: 1 (https://510kreport.com/company/trans1)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Exactech, Inc.: 1 (https://510kreport.com/company/exactech)
- Spine Wave, Inc.: 1 (https://510kreport.com/company/spine-wave)
- Orthofix, Inc.: 1 (https://510kreport.com/company/orthofix)

## Firms that cite its devices most
- Spinal Elements, Inc.: 2 (https://510kreport.com/company/spinal-elements)
- Hyprevention Sas: 1 (https://510kreport.com/company/hyprevention)
- Signature Orthopaedics Pty, Ltd.: 1 (https://510kreport.com/company/signature-orthopaedics)
- Box Spine, LLC: 1 (https://510kreport.com/company/box-spine)
- Vexim SA: 1 (https://510kreport.com/company/vexim)

## Its most-cited devices
- K132817: Kiva VCF Treatment System (2014), cited by 3
- K183560: Luna 3D GEN2 Interbody Fusion System (2019), cited by 2
- K142023: Luna Interbody System (2014), cited by 2
- K070293: Benvenue VCF Osteo Coil System (2007), cited by 1
- K193172: Luna XD Ti Interbody Fusion System (2020), cited by 1
- K162431: Luna 3D Interbody Fusion System (2016), cited by 1

## Recent decisions
- K201427: Trivergent Spinal Fixation System (Oct 21, 2020)
- K193172: Luna XD Ti Interbody Fusion System (Jul 2, 2020)
- K183560: Luna 3D GEN2 Interbody Fusion System (May 23, 2019)
- K162431: Luna 3D Interbody Fusion System (Nov 17, 2016)
- K142023: Luna Interbody System (Nov 20, 2014)
- K141141: Kiva VCF Treatment System (Aug 14, 2014)
- K132817: Kiva VCF Treatment System (Jan 24, 2014)
- K070293: Benvenue VCF Osteo Coil System (Jul 10, 2007)

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