Remex Medical Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Remex Medical Corp.” (first 2022, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 30 days. Since 2017 the median was 30 days, against 91 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 |
|---|---|---|
| 2022 | 1 | 157 |
| 2023 | 1 | 30 |
| 2024 | 3 | 29 |
| 2025 | 1 | 30 |
| 2026 | 1 | 30 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Remex Medical Corp. took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 7 | 7 |
Review panels
- Orthopedic (7)
Most recent Remex Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262506 | Remex Spine Surgery Navigation - Universal Instruments | OLO | 2026-08-20 | 30 |
| K251315 | Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II | OLO | 2025-05-29 | 30 |
| K243560 | Remex Spine Surgery Navigation Instrument | OLO | 2024-12-13 | 25 |
| K241625 | Anatase Navi Disposable Instrument | OLO | 2024-07-05 | 29 |
| K233513 | Remex Spine Surgery Navigation System II | OLO | 2024-05-01 | 182 |
| K230783 | Anatase Spine Surgery Navigation System | OLO | 2023-04-21 | 30 |
| K220348 | Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V | OLO | 2022-07-14 | 157 |
Recalls
openFDA lists no recalls under a recalling firm named Remex Medical Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Remex Medical Corp.?
FDA lists 7 510(k) clearances under the applicant name “Remex Medical Corp.” (first 2022, latest 2026), across 1 product code 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 Remex Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Remex Medical Corp. is 30 days. Since 2017: 30 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Remex Medical Corp.?
The most frequent FDA product codes under this applicant name are OLO (Orthopedic Stereotaxic Instrument, 7).
Next steps
- See all 7 Remex Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code OLO, Remex Medical Corp.'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.