# Xenco Medical, LLC

- Location (FDA's records): San Diego, CA
- FDA decisions: 16 (2014–2025): 16 510(k) clearances
- Product codes: ODP (4), NKB (3), MAX (3), MQV (2), OVE (2), KWQ (1), NKG (1)
- 510(k) review time since 2016: median 98 days, against 90 for FDA's reviews in the same codes and years (4 of 11 faster)
- Predicates its devices cite: 12 (4 its own); citations of its devices by later devices: 7 (4 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
- Haider Biologics, LLC: 2 (https://510kreport.com/company/haider-biologics)
- Astura Medical: 1 (https://510kreport.com/company/astura-medical)
- Biomet Spine: 1 (https://510kreport.com/company/biomet-spine)
- K2m, Inc.: 1 (https://510kreport.com/company/k2m)
- Spinal Elements, Inc.: 1 (https://510kreport.com/company/spinal-elements)
- Nvision Biomedical Technologies, Inc.: 1 (https://510kreport.com/company/nvision-biomedical-technologies)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)

## Firms that cite its devices most
- Ctl Medical Corporation: 1 (https://510kreport.com/company/ctl-medical)
- Eminent Spine: 1 (https://510kreport.com/company/eminent-spine)
- Aegis Spine, Inc.: 1 (https://510kreport.com/company/aegis-spine)

## Its most-cited devices
- K143158: Xenco Medical Lumbar Interbody System (2015), cited by 3
- K140786: Xenco Medical Cervical Interbody System (2014), cited by 2
- K190364: CancelleX Porous Titanium Lumbar Interbody Device (2019), cited by 1
- K160313: Xenco Medical Cervical Interbody System (2016), cited by 1

## Recent decisions
- K243673: Xenco Medical CancelleX Cervical Interbody System (Jan 29, 2025)
- K223059: Xenco Medical InterAlign Cervical Interbody System (Jun 7, 2023)
- K213456: Xenco Medical Multilevel CerviKit (Dec 21, 2021)
- K191074: Sorrento Bone Graft Substitute (Sep 27, 2019)
- K190364: CancelleX Porous Titanium Lumbar Interbody Device (Apr 18, 2019)
- K173933: Sorrento Bioglass Bone Graft Substitute (Sep 13, 2018)
- K180373: CancelleX Porous Titanium Lumbar Interbody Device (Aug 24, 2018)
- K170611: SETx Pedicle Screw System (May 25, 2017)

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