510(k) Report

FDA applicant

Medynus, Inc.

Irvine, CA3 decisions2021–20220 recalls

FDA records 3 decisions for Medynus, Inc. (Irvine, CA) from 2021 to 2022: 3 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Since 2016 its 510(k)s took a median of 22 days from receipt to decision, against 85 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 Medynus, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2021: 22022: 1
2021high 2 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Medynus, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medynus, Inc.’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

Which product codes does it file in?

  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 22 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 85 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 1 time; 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.

  • K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc. · 20211cites it

What has FDA decided for it lately?

  • K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemMedynus, Inc. · 2022
  • K212792Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK CageMedynus, Inc. · 2021
  • K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc. · 2021

All 3 as Medynus, Inc. →