Ulrich Medical USA: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Ulrich Medical USA” (first 2015, latest 2026), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 86 days. Since 2017 the median was 75 days, against 88 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 98 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 121 |
| 2019 | 1 | 75 |
| 2020 | 1 | 163 |
| 2021 | 0 | — |
| 2022 | 2 | 99 |
| 2023 | 2 | 90 |
| 2024 | 2 | 16 |
| 2025 | 1 | 27 |
| 2026 | 1 | 216 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ulrich Medical USA took a median 75 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| OLO | Orthopedic Stereotaxic Instrument | 2 | 2 |
| MQP | Spinal Vertebral Body Replacement Device | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
| PML | Bone Cement, Posterior Screw Augmentation | 1 | 1 |
Review panels
- Orthopedic (12)
Most recent Ulrich Medical USA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252087 | Navigation Module of the Cortium® System | OLO | 2026-02-03 | 216 |
| K251719 | Momentum® Posterior Spinal Fixation System | NKB | 2025-07-01 | 27 |
| K241396 | uCerv Flux-C 3D Porous Titanium Cervical Interbody | ODP | 2024-05-23 | 7 |
| K240515 | uNion® MAX Cervical Plate System | KWQ | 2024-03-18 | 24 |
| K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement | PML | 2023-10-20 | 122 |
| K230614 | Cortium | NKG | 2023-05-02 | 57 |
| K223274 | Momentum® MIS Posterior Spinal Fixation System | NKB | 2022-11-28 | 35 |
| K220696 | uCerv Flux-C 3D Porous Titanium Cervical Interbody | ODP | 2022-08-19 | 163 |
| K200845 | Navigation Module of the Momentum System | OLO | 2020-09-10 | 163 |
| K191932 | Momentum Posterior Spinal Fixation System | NKB | 2019-10-02 | 75 |
2 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2019-12-31.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ulrich GmbH & Co. KG (24 510(k)s)
- Ulrich Alber GmbH (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ulrich Medical USA?
FDA lists 12 510(k) clearances under the applicant name “Ulrich Medical USA” (first 2015, latest 2026), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ulrich Medical USA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ulrich Medical USA is 86 days. Since 2017: 75 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ulrich Medical USA?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 3); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 2).
Next steps
- See all 12 Ulrich Medical USA clearances with predicates and recalls
- Run predicate analysis for product code NKB, Ulrich Medical USA's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.