510(k) Report

FDA applicant

Omni Surgical, L.P.

Round Rock, TX2 decisions2009–20112 recalls

FDA records 2 decisions for Omni Surgical, L.P. (Round Rock, TX) from 2009 to 2011: 2 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Its devices cite 5 predicates, 0 of them its own earlier devices. 2 recalls are 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, L.P.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2009: 12011: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2016

2016: 2
2009high 2 (2016) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Omni Surgical, L.P. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Omni Surgical, L.P.’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?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K081770Black Widow Anterior Buttress PlateOmni Surgical, L.P. · 20093cite it
  • K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant (Tlif); Great White…Omni Surgical, L.P. · 20111cites it

What has FDA decided for it lately?

  • K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant (Tlif); Great White…Omni Surgical, L.P. · 2011
  • K081770Black Widow Anterior Buttress PlateOmni Surgical, L.P. · 20092 recalls

All 2 as Omni Surgical, L.P. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K081770Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part…Nov 22, 2016Class II
  • K081770Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part…Nov 22, 2016Class II

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-Guide Holdings, Inc. 2Omni Sales Corp. 2Omni Mfg., Inc. 1Omni Medical Designs 1Omni-Flow, Inc. 1Omni Surgical, LLC Dba Spine360 1Omni Surgical, LP Dba Spine360 1