510(k) Report

FDA applicant

Triage Medical, Inc.

Irvine, CA11 decisions2001–20062 recalls

FDA records 11 decisions for Triage Medical, Inc. (Irvine, CA) from 2001 to 2006: 11 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and MRW (System, Facet Screw Spinal Device). Its devices cite 5 predicates, 2 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 Triage Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Triage Medical, Inc. since 2007.

Recalls per year

2in 2011

2011: 2
2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Triage Medical, Inc.’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?

  • HWCScrew, Fixation, Bone6decisions
  • MRWSystem, Facet Screw Spinal Device4decisions
  • HTNWasher, Bolt Nut1decision

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 2 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.

  • K0433514.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or NTriage Medical, Inc. · 20053cite it
  • K0520433.8MM CS Facet Compression DeviceTriage Medical, Inc. · 20052cite it
  • K042244Bone-Lok MVP Cortical-Cancellous Compression DeviceTriage Medical, Inc. · 20041cites it
  • K062391Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02; Compression Tool, Model…Triage Medical, Inc. · 20061cites it

What has FDA decided for it lately?

  • K062391Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02; Compression Tool, Model…Triage Medical, Inc. · 20061 recall
  • K0520433.8MM CS Facet Compression DeviceTriage Medical, Inc. · 2005
  • K0519494.5 MM LS Facet Compression Device with Polymer Washer, Model LSPW-45-3040Triage Medical, Inc. · 2005
  • K0433514.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or NTriage Medical, Inc. · 20051 recall
  • K042244Bone-Lok MVP Cortical-Cancellous Compression DeviceTriage Medical, Inc. · 2004
  • K040250Bone-Lok HP WasherTriage Medical, Inc. · 2004
  • K014304Bone-Lok Bioabsorbable Compression Anchor, Model BMCD-35-3050STriage Medical, Inc. · 2002
  • K014243Bone-Lok Bioabsorbable Compression Anchor with Titanium Fixture , Model BMCD-35-3040, MBCD-35-4050Triage Medical, Inc. · 2002

All 11 as Triage Medical, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K062391PERPOS PLS, CATALOG #'s 9045-01 & 9045-02 A sterile, medical device kit consisting of…Mar 15, 2011
  • K043351Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated…Mar 15, 2011