510(k) Report

FDA applicant

Omni Surgical, LLC Dba Spine360

Austin, TX1 decision2014–20140 recalls

FDA records 1 decision for Omni Surgical, LLC Dba Spine360 (Austin, TX) in 2014: 1 510(k) clearance. All are in product code KWP (Appliance, Fixation, Spinal Interlaminal). Its devices cite 1 predicate, 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 Omni Surgical, LLC Dba Spine360’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 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 — Omni Surgical, LLC Dba Spine360 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?

  • KWPAppliance, Fixation, Spinal Interlaminal1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K132122Kestrel Posterior Cervical Spine SystemOmni Surgical, LLC Dba Spine360 · 20141cites it

What has FDA decided for it lately?

  • K132122Kestrel Posterior Cervical Spine SystemOmni Surgical, LLC Dba Spine360 · 2014

The one decision as Omni Surgical, LLC Dba Spine360 →

Other applicant names beginning “Omni”

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

Omni Life Science, Inc. 21Omni Intl., Inc. 12Omni Hearing Systems 7Omni Therm, Inc. 5Omni-Tract Surgical, Div. Minn. Scientific, Inc. 4Omni Surgical, L.P. 2Omni-Guide Holdings, Inc. 2Omni Sales Corp. 2Omni Mfg., Inc. 1Omni Medical Designs 1Omni-Flow, Inc. 1Omni Surgical, LP Dba Spine360 1