510(k) Report

FDA applicant

Xenco Medical, LLC

San Diego, CA16 decisions2014–20250 recalls

FDA records 16 decisions for Xenco Medical, LLC (San Diego, CA) from 2014 to 2025: 16 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 98 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Xenco Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2014: 12015: 42016: 32017: 12018: 22019: 22021: 12023: 12025: 1
2014high 4 (2015) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Xenco Medical, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Xenco Medical, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • ODPIntervertebral Fusion Device With Bone Graft, Cervical4decisions
  • NKBThoracolumbosacral Pedicle Screw System3decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar3decisions
  • MQVFiller, Bone Void, Calcium Compound2decisions
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical2decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision

Also: NKG (1).

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 98 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 4 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K143158Xenco Medical Lumbar Interbody SystemXenco Medical, LLC · 20153cite it
  • K140786Xenco Medical Cervical Interbody SystemXenco Medical, LLC · 20142cite it
  • K190364CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC · 20191cites it
  • K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC · 20161cites it

What has FDA decided for it lately?

  • K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC · 2025
  • K223059Xenco Medical InterAlign Cervical Interbody SystemXenco Medical, LLC · 2023
  • K213456Xenco Medical Multilevel CerviKitXenco Medical, LLC · 2021
  • K191074Sorrento Bone Graft SubstituteXenco Medical, LLC · 2019
  • K190364CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC · 2019
  • K173933Sorrento Bioglass Bone Graft SubstituteXenco Medical, LLC · 2018
  • K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC · 2018
  • K170611SETx Pedicle Screw SystemXenco Medical, LLC · 2017

All 16 as Xenco Medical, LLC →