510(k) Report

FDA applicant

Getset Surgical, SA

Vaud, CH2 decisions2021–20250 recalls

FDA records 2 decisions for Getset Surgical, SA (Vaud, CH) from 2021 to 2025: 2 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 2 predicates, 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 Getset Surgical, SA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 12025: 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 — Getset Surgical, SA by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA · 2025
  • K202505GetSet Surgical GoPLF! Posterior Lateral Fusion SystemGetset Surgical, SA · 2021

All 2 as Getset Surgical, SA →