510(k) Report

FDA applicant

Amplify Surgical, Inc.

Irvine, CA3 decisions2019–20220 recalls

FDA records 3 decisions for Amplify Surgical, Inc. (Irvine, CA) from 2019 to 2022: 3 510(k) clearances. All are in product code MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 109 for FDA’s reviews in the same codes and years. Its devices cite 7 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 Amplify Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2019: 12021: 12022: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Amplify Surgical, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Amplify Surgical, Inc.’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?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 85 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 109 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 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.

  • K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc. · 20221cites it
  • K211740DualXAmplify Surgical, Inc. · 20211cites it

What has FDA decided for it lately?

  • K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc. · 2022
  • K211740DualXAmplify Surgical, Inc. · 2021
  • K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc. · 2019

All 3 as Amplify Surgical, Inc. →