510(k) Report

FDA applicant

Auxein Medical Private Limited/71164

Sonipat, IN1 decision2021–20210 recalls

FDA records 1 decision for Auxein Medical Private Limited/71164 (Sonipat, IN) in 2021: 1 510(k) clearance. All are in product code NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 1 predicate, 0 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 Auxein Medical Private Limited/71164’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Auxein Medical Private Limited/71164 by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Auxein Medical Private Limited/71164’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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Which product codes does it file in?

  • NKBThoracolumbosacral Pedicle Screw System1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/71164 · 20212cite it

What has FDA decided for it lately?

  • K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/71164 · 2021

The one decision as Auxein Medical Private Limited/71164 →

Other applicant names beginning “Auxein”

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

Auxein Medical Private Limited 12Auxein Medical 1Auxein Medical Pvt., Ltd. 1