FDA applicant

Elite Surgical Supplies (Pty), Ltd.

Marietta, GA4 decisions2007–20200 recalls

FDA records 4 decisions for Elite Surgical Supplies (Pty), Ltd. (Marietta, GA) from 2007 to 2020: 4 510(k) clearances. Most are in product codes MNI (Orthosis, Spinal Pedicle Fixation) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Its devices cite 7 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

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Elite Surgical Supplies (Pty), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Elite Surgical Supplies (Pty), Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Elite Surgical Supplies (Pty), Ltd.’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

Other applicant names beginning “Elite”

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

Elite Diagnostic, Ltd. 5 Elite Technology, Inc. 5 Elite International, Inc. 4 Elite Electromedical 1 Elite Biomedical Solutions 1 Elite Medical Supply of New York, LLC 1 Elite Medical, Inc. 1

Elite Surgical Supplies (Pty), Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Elite”