510(k) Report

FDA applicant

Ulrich Medical USA

Chesterfield, MO12 decisions2015–20261 recall

FDA records 12 decisions for Ulrich Medical USA (Chesterfield, MO) from 2015 to 2026: 12 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and OLO (Orthopedic Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 75 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 39 predicates, 6 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Ulrich Medical USA, Inc.”.

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 Ulrich Medical USA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2015: 12018: 12019: 12020: 12022: 22023: 22024: 22025: 12026 (partial year): 1
2015high 2 (2022) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2015high 1 (2017) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Ulrich Medical USA by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ulrich Medical USA’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?

  • NKBThoracolumbosacral Pedicle Screw System3decisions
  • OLOOrthopedic Stereotaxic Instrument2decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body2decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical2decisions
  • MQPSpinal Vertebral Body Replacement Device1decision
  • PMLBone Cement, Posterior Screw Augmentation1decision

Also: NKG (1).

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 75 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 88 days; 7 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 39 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 6 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.

  • K150666uNion Cervical Plate SystemUlrich Medical USA · 20153cite it
  • K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 20192cite it
  • K181921Solidity Vertebral Body ReplacementUlrich Medical USA · 20181cites it
  • K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA · 20221cites it
  • K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal…Ulrich Medical USA · 20231cites it
  • K223274Momentum® MIS Posterior Spinal Fixation SystemUlrich Medical USA · 20221cites it

What has FDA decided for it lately?

  • K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc. · 2026
  • K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025
  • K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc. · 2024
  • K240515uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc. · 2024
  • K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal…Ulrich Medical USA · 2023
  • K230614Cortium™Ulrich Medical USA · 2023
  • K223274Momentum® MIS Posterior Spinal Fixation SystemUlrich Medical USA · 2022
  • K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA · 2022

All 8 as Ulrich Medical USA →All 4 as Ulrich Medical USA, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K150666uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended…Mar 7, 2017Class II

Other applicant names beginning “Ulrich”

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

Ulrich GmbH & Co. KG 24Ulrich Alber GmbH 2