510(k) Report

FDA applicant

Frontier Medical Devices, Inc.

Gwinn, MI5 decisions2012–20160 recalls

FDA records 5 decisions for Frontier Medical Devices, Inc. (Gwinn, MI) from 2012 to 2016: 5 510(k) clearances. Most are in product codes JDQ (Cerclage, Fixation) and OVD (Intervertebral Fusion Device With Integrated…). Its devices cite 14 predicates, 2 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 Frontier Medical Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2012: 12015: 32016: 1
2012high 3 (2015) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Frontier Medical Devices, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JDQCerclage, Fixation3decisions
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar2decisions

Whose devices does it build on?

Its devices cite 14 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc. · 20121cites it
  • K151888Frontier Medical Devices In-line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc. · 20151cites it

What has FDA decided for it lately?

  • K153242Frontier Medical Devices In-Line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc. · 2016
  • K151888Frontier Medical Devices In-line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc. · 2015
  • K151346Frontier Medical Devices Posterior Cable Screw SystemFrontier Medical Devices, Inc. · 2015
  • K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc. · 2015
  • K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc. · 2012

All 5 as Frontier Medical Devices, Inc. →

Other applicant names beginning “Frontier”

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

Frontier Products 4Frontier Novelty, Inc. 4Frontier Devices, Inc. 1