FDA applicant

Matrix Surgical Holdings, LLC/Matrix Surgical USA

Atlanta, GA2 decisions2014–20181 recall

FDA records 2 decisions for Matrix Surgical Holdings, LLC/Matrix Surgical USA (Atlanta, GA) from 2014 to 2018: 2 510(k) clearances. Most are in product codes JEY (Plate, Bone) and KKY (Material, Polytetrafluoroethylene Vitreous…). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 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, dental panel, where it files most

How often FDA has decided Matrix Surgical Holdings, LLC/Matrix Surgical USA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2017

2014high 1 (2017) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Matrix Surgical Holdings, LLC/Matrix Surgical USA by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Matrix Surgical Holdings, LLC/Matrix…’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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Other applicant names beginning “Matrix”

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

Matrix Medica, Inc. 14 Matrix Instruments 4 Matrix Technologies Corp. 3 Matrix Electromedical, Inc. 2 Matrix Biokinetics, Inc. 1 Matrix Surgical USA 1 Matrix Intl. 1

Matrix Surgical Holdings, LLC/Matrix Surgical USA

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Matrix”