510(k) Report

FDA applicant

Emerge Medical

Denver, CO11 decisions2010–20140 recalls

FDA records 11 decisions for Emerge Medical (Denver, CO) from 2010 to 2014: 11 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Its devices cite 51 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Emerge Medical, Inc.”.

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 Emerge Medical’s devices, and how often a recall has named them.

FDA decisions per year

8in 2014

2010: 12012: 12013: 12014: 8
2010high 8 (2014) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Emerge Medical by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Emerge Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HRSPlate, Fixation, Bone7decisions
  • HWCScrew, Fixation, Bone2decisions
  • HSBRod, Fixation, Intramedullary And Accessories1decision
  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1decision

Whose devices does it build on?

Its devices cite 51 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K140119Emerge Medical Periarticular and Locking Large Fragment SystemEmerge Medical · 20141cites it
  • K122489Emerge Medical Solid Bone ScrewsEmerge Medical · 20121cites it
  • K140675Emerge External Fixation SystemEmerge Medical, Inc. · 20141cites it
  • K102343Emerge Medical Cannulated Screw Fixation SystemEmerge Medical · 20101cites it

What has FDA decided for it lately?

  • K141347Emerge Medical IM Nail SystemEmerge Medical · 2014
  • K140675Emerge External Fixation SystemEmerge Medical, Inc. · 2014
  • K140107Emerge Medical Distal Radius SetEmerge Medical · 2014
  • K140119Emerge Medical Periarticular and Locking Large Fragment SystemEmerge Medical · 2014
  • K140098Emerge Medical Small Fragment Locked Plating SystemEmerge Medical · 2014
  • K133536Emerge Medical Bone Plate SystemEmerge Medical · 2014
  • K133541Emerge Medical Small and Large Non-Locking Fragment Plate SystemEmerge Medical · 2014
  • K133452Emerge Medical Small Fragment Locked Plating SystemEmerge Medical · 2014

All 10 as Emerge Medical →The one decision as Emerge Medical, Inc. →