510(k) Report

FDA applicant

Southern Spine, LLC

Alpharetta, GA4 decisions2007–20210 recalls

FDA records 4 decisions for Southern Spine, LLC (Alpharetta, GA) from 2007 to 2021: 4 510(k) clearances. Most are in product codes KWP (Appliance, Fixation, Spinal Interlaminal) and ODP (Intervertebral Fusion Device With Bone Graft…). Its devices cite 14 predicates, 0 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 Southern Spine, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 12012: 12013: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Southern Spine, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Southern 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?

  • KWPAppliance, Fixation, Spinal Interlaminal1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision

Whose devices does it build on?

Its devices cite 14 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 0 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.

  • K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 20123cite it
  • K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC · 20133cite it

What has FDA decided for it lately?

  • K211845Deploy Expandable Interbody SystemSouthern Spine, LLC · 2021
  • K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC · 2013
  • K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012
  • K063764Southern Spine Anterior Cervical Stabilization System, Kwik- Fix Cervical System, and Kwik-Fix / TS Cervical…Southern Spine, LLC · 2007

All 4 as Southern Spine, LLC →