510(k) Report

FDA applicant

Cardinal Spine, LLC

San Diego, CA4 decisions2011–20160 recalls

FDA records 4 decisions for Cardinal Spine, LLC (San Diego, CA) from 2011 to 2016: 4 510(k) clearances. Most are in product codes MQP (Spinal Vertebral Body Replacement Device) and PLR (Spinal Vertebral Body Replacement Device -…). Its devices cite 12 predicates, 3 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 Cardinal Spine, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2011: 12012: 12015: 12016: 1
2011high 1 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Cardinal Spine, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • MQPSpinal Vertebral Body Replacement Device2decisions
  • PLRSpinal Vertebral Body Replacement Device - Cervical1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision

Whose devices does it build on?

Its devices cite 12 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 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.

  • K152568C-VBRCardinal Spine, LLC · 20164cite it
  • K121176STGCCardinal Spine, LLC · 20122cite it
  • K142030STGC-LordoticCardinal Spine, LLC · 20151cites it
  • K100698STCCCardinal Spine, LLC · 20111cites it

What has FDA decided for it lately?

  • K152568C-VBRCardinal Spine, LLC · 2016
  • K142030STGC-LordoticCardinal Spine, LLC · 2015
  • K121176STGCCardinal Spine, LLC · 2012
  • K100698STCCCardinal Spine, LLC · 2011

All 4 as Cardinal Spine, LLC →

Other applicant names beginning “Cardinal”

FDA records each applicant name separately; these may or may not be the same firm.

Cardinal Health, Inc. 28Cardinal Health200, LLC 26Cardinal Health, Alaris Products 9Cardinal Health-Medical Products and Services 6Cardinal Health 207, Inc. 5Cardinal Health 200, Inc. 4Cardinal Health 303,Inc. 4Cardinal Health Germany 234 GmbH 2Cardinal Scale Mfg. Co. 1