NGMedical GmbH: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “NGMedical GmbH” (first 2021, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 154 days. Since 2017 the median was 154 days, against 109 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 |
|---|---|---|
| 2021 | 4 | 134 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 245 |
| 2025 | 1 | 269 |
| 2026 | 1 | 29 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name NGMedical GmbH took a median 154 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 | 4 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
Review panels
- Orthopedic (7)
Most recent NGMedical GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261067 | BEE PLIF Cage | MAX | 2026-04-30 | 29 |
| K250560 | BEE HA | ODP | 2025-11-21 | 269 |
| K231371 | BEE Cervical Cage | ODP | 2024-01-12 | 245 |
| K212050 | NGM WAVE PLIF Cage | MAX | 2021-12-01 | 154 |
| K211413 | BEE PLIF Cage | MAX | 2021-08-27 | 113 |
| K203444 | BEE HA Cage | ODP | 2021-03-18 | 115 |
| K200429 | BEE Cages | ODP | 2021-01-29 | 343 |
Recalls
openFDA lists no recalls under a recalling firm named NGMedical GmbH.
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.
Device clinical trials
An industry sponsor named NGMedical GmbH is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05035693: Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C (Recruiting, started 2021-03-11)
Frequently asked questions
How many FDA 510(k) clearances are listed under NGMedical GmbH?
FDA lists 7 510(k) clearances under the applicant name “NGMedical GmbH” (first 2021, latest 2026), across 2 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 NGMedical GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name NGMedical GmbH is 154 days. Since 2017: 154 days, versus 109 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under NGMedical GmbH?
The most frequent FDA product codes under this applicant name are ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 4); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 3).
Next steps
- See all 7 NGMedical GmbH clearances with predicates and recalls
- Run predicate analysis for product code ODP, NGMedical GmbH'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.