510(k) Report

FDA applicant

Facet-Link, Inc.

Rockaway, NJ2 decisions2013–20150 recalls

FDA records 2 decisions for Facet-Link, Inc. (Rockaway, NJ) from 2013 to 2015: 2 510(k) clearances. All are in product code MRW (System, Facet Screw Spinal Device). Its devices cite 3 predicates, 1 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

How often FDA has decided Facet-Link, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2013: 12015: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Facet-Link, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MRWSystem, Facet Screw Spinal Device2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 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.

  • K123497Facet Screw SystemFacet-Link, Inc. · 20131cites it

What has FDA decided for it lately?

  • K150223Facet-Link Stabilization PlatformFacet-Link, Inc. · 2015
  • K123497Facet Screw SystemFacet-Link, Inc. · 2013

All 2 as Facet-Link, Inc. →

Other applicant names beginning “Facet-Link”

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

Facet Technologies, LLC 8