510(k) Report

FDA applicant

Corelink, LLC

St. Louis, MO35 decisions2008–20230 recalls

FDA records 35 decisions for Corelink, LLC (St. Louis, MO) from 2008 to 2023: 35 510(k) clearances. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 164 predicates, 47 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 Corelink, LLC’s devices, and how often a recall has named them.

FDA decisions per year

6in 2023

2008: 12011: 12012: 52013: 32014: 12015: 12016: 12017: 22018: 32019: 22020: 32021: 22022: 42023: 6
2008high 6 (2023) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Corelink, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Corelink, 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?

  • OLOOrthopedic Stereotaxic Instrument7decisions
  • NKBThoracolumbosacral Pedicle Screw System6decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body5decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar4decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical3decisions
  • OURSacroiliac Joint Fixation2decisions

Also: OVE (2), NKG (1), MQP (1), KWP (1), MNI (1), MNH (1).

How long do its 510(k) reviews take?

Since 2016, its 23 510(k)s took a median of 120 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; 10 of its 23 were faster than that.

Whose devices does it build on?

Its devices cite 164 predicates; 47 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 103 times; 47 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.

  • K162496Foundation 3D InterbodyCorelink, LLC · 201710cite it
  • K113058Tiger Spine SystemCorelink, LLC · 20129cite it
  • K133369Tiger Spine SystemCorelink, LLC · 20147cite it
  • K110321Tiger Spine SystemCorelink, LLC · 20116cite it
  • K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC · 20186cite it
  • K073440Foundation CageCorelink, LLC · 20085cite it

What has FDA decided for it lately?

  • K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate SystemCorelink, LLC · 2023
  • K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC · 2023
  • K232116CoreLink Navigation InstrumentsCorelink, LLC · 2023
  • K230329F3D Interbody SystemCorelink, LLC · 2023
  • K230880CoreLink Navigation InstrumentsCorelink, LLC · 2023
  • K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023
  • K221776NextGen Pedicle Screw SystemCorelink, LLC · 2022
  • K220973CoreLink Navigation InstrumentsCorelink, LLC · 2022

All 35 as Corelink, LLC →