# Spinal Elements, Inc.

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 50 (2007–2026): 50 510(k) clearances
- Names in FDA's records: Spinal Elements, Inc. (49); Spinal Elements (1)
- Product codes: MAX (17), NKB (11), OVE (4), KWQ (4), OVD (3), OWI (2), ODP (2), KWP (1), MRW (1), FST (1), PEK (1), JDQ (1)
- 510(k) review time since 2016: median 131 days, against 95 for FDA's reviews in the same codes and years (5 of 25 faster)
- Predicates its devices cite: 157 (89 its own); citations of its devices by later devices: 211 (89 its own)
- Recalls linked to its devices: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Amendia, Inc.: 7 (https://510kreport.com/company/amendia)
- Depuyacromed: 5 (https://510kreport.com/company/depuyacromed)
- Medtronic Sofamor Danek: 4 (https://510kreport.com/company/medtronic-sofamor-danek)
- Medtronic Sofamor Danek USA, Inc.: 4 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Synthes Spine: 3 (https://510kreport.com/company/synthes-spine)
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- NGMedical GmbH: 3 (https://510kreport.com/company/ngmedical)
- Stryker Spine: 2 (https://510kreport.com/company/stryker-spine)

## Firms that cite its devices most
- Astura Medical: 8 (https://510kreport.com/company/astura-medical)
- Nexus Spine, LLC: 6 (https://510kreport.com/company/nexus-spine)
- Spineart: 5 (https://510kreport.com/company/spineart)
- Aesculap Implant Systems, LLC: 4 (https://510kreport.com/company/aesculap-implant-systems)
- Life Spine, Inc.: 3 (https://510kreport.com/company/life-spine)
- Southern Medical (Pty), Ltd.: 3 (https://510kreport.com/company/southern-medical)
- Next Orthosurgical: 3 (https://510kreport.com/company/next-orthosurgical)
- Nuvasive, Inc.: 3 (https://510kreport.com/company/nuvasive)

## Its most-cited devices
- K071724: Lucent (2007), cited by 39
- K073351: Crystal (2008), cited by 27
- K110632: Lucent or Lucent Magnum (2012), cited by 12
- K081968: Modification to Lucent (2008), cited by 12
- K150061: Lucent; Lucent Ti-Bond Systems (2015), cited by 10
- K083475: Lucent Magnum (2009), cited by 10

## Recent decisions
- K260506: Ventana® P/T Lumbar Interbody System (May 15, 2026)
- K253559: Ventana™ A Anterior Lumbar Interbody System (Feb 25, 2026)
- K250773: Luna® Ti Interbody Fusion System (Feb 4, 2026)
- K242527: The Karma® Fixation System (May 21, 2025)
- K243916: Primus Spinal Fixation System (Feb 21, 2025)
- K234150: Lucent® XP (Mar 27, 2024)
- K231593: Sapphire X3 Anterior Cervical Plate System (Aug 2, 2023)
- K231252: Ventana™ L Spinal System (Jun 30, 2023)

Source page: https://510kreport.com/company/spinal-elements