Met One Technologies, LLC: FDA clearances and approvals
Met One Technologies, LLC has 7 FDA 510(k) clearances (first 2017, latest 2026), across 6 product codes in 1 review panel. Median 510(k) review time: 110 days. Since 2017 its median was 110 days, against 90 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 110 |
| 2018 | 1 | 269 |
| 2019 | 0 | — |
| 2020 | 1 | 148 |
| 2021 | 0 | — |
| 2022 | 1 | 97 |
| 2023 | 1 | 59 |
| 2024 | 0 | — |
| 2025 | 1 | 57 |
| 2026 | 1 | 251 |
Review time against the same product codes
Since 2017, Met One Technologies, LLC's cleared 510(k)s took a median 110 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Met One Technologies, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251732 | Wrist Fracture System | HRS | 2026-02-12 | 251 |
| K250866 | Sovereign Posterior Cervical System | NKG | 2025-05-20 | 57 |
| K230851 | Kodiak Lumbar Spacer System | MAX | 2023-05-26 | 59 |
| K222806 | Kodiak C Spinal Implant System | ODP | 2022-12-22 | 97 |
| K193457 | AUDERE Lumbar Spacer System | MAX | 2020-05-12 | 148 |
| K180772 | Met One Czar Anterior Cervical Plate System | KWQ | 2018-12-17 | 269 |
| K170108 | Xultan 5.5 Pedicle Screw System | NKB | 2017-05-02 | 110 |
Recalls
openFDA lists no recalls under a recalling firm named Met One Technologies, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Met One Technologies, LLC have?
Met One Technologies, LLC has 7 FDA 510(k) clearances (first 2017, latest 2026), across 6 product codes in 1 review panel.
How long does FDA take to clear Met One Technologies, LLC's 510(k)s?
The median time from FDA receipt to decision across Met One Technologies, LLC's cleared 510(k)s is 110 days. Since 2017: 110 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Met One Technologies, LLC make?
Its most frequent FDA product codes are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2); HRS (Plate, Fixation, Bone, 1); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1).
Has Met One Technologies, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Met One Technologies, LLC. Related entities may recall under other names.
Next steps
- See all 7 Met One Technologies, LLC clearances with predicates and recalls
- Run predicate analysis for product code MAX, Met One Technologies, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.