# Spineart

- Location (FDA's records): Geneva, CH
- FDA decisions: 58 (2008–2026): 58 510(k) clearances
- Names in FDA's records: Spineart (44); Spineart SA (14)
- Product codes: MAX (12), NKB (7), OLO (7), ODP (6), MNH (5), MNI (5), OVD (4), NKG (3), OVE (3), KWQ (2), PEK (1), GAD (1)
- 510(k) review time since 2016: median 66 days, against 92 for FDA's reviews in the same codes and years (25 of 36 faster)
- Predicates its devices cite: 224 (116 its own); citations of its devices by later devices: 148 (116 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Sofamor Danek USA, Inc.: 16 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Stryker Spine: 6 (https://510kreport.com/company/stryker-spine)
- SeaSpine Orthopedics Corporation: 6 (https://510kreport.com/company/seaspine-orthopedics)
- Nuvasive, Inc.: 5 (https://510kreport.com/company/nuvasive)
- K2m, Inc.: 5 (https://510kreport.com/company/k2m)
- Spinal Elements, Inc.: 5 (https://510kreport.com/company/spinal-elements)
- X-Spine Systems, Inc.: 4 (https://510kreport.com/company/x-spine-systems)
- Lanx, Inc.: 4 (https://510kreport.com/company/lanx)

## Firms that cite its devices most
- L&K BIOMED Co., Ltd.: 7 (https://510kreport.com/company/l-k-biomed)
- Accel Spine: 3 (https://510kreport.com/company/accel-spine)
- Signature Orthopaedics Pty, Ltd.: 2 (https://510kreport.com/company/signature-orthopaedics)
- Solco Biomedical Co., Ltd.: 2 (https://510kreport.com/company/solco-biomedical)
- Qualgenix: 2 (https://510kreport.com/company/qualgenix)
- Neo Medical SA: 2 (https://510kreport.com/company/neo-medical)
- Eit Emerging Implant Technologies GmbH: 1 (https://510kreport.com/company/eit-emerging-implant-technologies)
- Zavation, LLC: 1 (https://510kreport.com/company/zavation)

## Its most-cited devices
- K081888: Dynamik Intervertebral Body Fusion Device (2009), cited by 13
- K081165: Ellipse Lumbar Posterior Osteosynthesis System (2008), cited by 12
- K091873: Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-S (2009), cited by 10
- K153621: Juliet® Ti (2016), cited by 8
- K101720: Juliet OL (2010), cited by 8
- K101678: Romeo Posterior Osteosynthesis System (2010), cited by 6

## Recent decisions
- K261049: Scala® TL (Aug 20, 2026)
- K262639: BAGUERA® C Cervical Disc Surgical Instruments (Aug 14, 2026)
- K261205: SPINEART Navigation Instrument System (Jul 29, 2026)
- K253966: PERLA® TL Posterior Thoraco-lumbar Fixation System (May 1, 2026)
- K254158: SPINEART Navigation Instrument System (Apr 9, 2026)
- K242933: SPINEART Navigation Instrument System (Jun 18, 2025)
- K242890: SPINEART Navigation Instrument System (Mar 7, 2025)
- K242589: Scarlet® AL-T (Oct 23, 2024)

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