510(k) Report

FDA applicant

Spine Smith Holdings, LLC

Austin, TX3 decisions2014–20200 recalls

FDA records 3 decisions for Spine Smith Holdings, LLC (Austin, TX) from 2014 to 2020: 3 510(k) clearances. Most are in product codes OVE (Intervertebral Fusion Device With Integrated…) and KNW (Instrument, Biopsy). Its devices cite 4 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 Spine Smith Holdings, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2014: 12018: 12020: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

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

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Which product codes does it file in?

  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical1decision
  • KNWInstrument, Biopsy1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC · 2020
  • K180807Celling Aspiration NeedleSpine Smith Holdings, LLC · 2018
  • K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC · 2014

All 3 as Spine Smith Holdings, LLC →