Scien'Tx USA, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Scien'Tx USA, Inc.” (first 1999, latest 2002), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 76 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 4 | 4 |
| MNI | Orthosis, Spinal Pedicle Fixation | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
- Orthopedic (8)
Most recent Scien'Tx USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020245 | MODIFICATION TO ISOBAR SPINAL SYSTEM | MNH | 2002-02-01 | 8 |
| K013447 | ISOBAR SPINAL SYSTEM | KWP | 2002-01-15 | 90 |
| K013439 | ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2002-01-14 | 89 |
| K013444 | ISOBAR SPINAL SYSTEM | MNH | 2001-11-16 | 30 |
| K013440 | ISOBAR SPINAL SYSTEM | MNI | 2001-11-16 | 30 |
| K991326 | ISOBAR SEMI-RIGID SPINAL SYSTEM | MNI | 1999-11-08 | 203 |
| K990721 | ISOLOCK SPINAL SYSTEM | MNH | 1999-05-27 | 83 |
| K990118 | ISOBAR SPINAL SYSTEM | MNH | 1999-03-22 | 68 |
Recalls
openFDA lists no recalls under a recalling firm named Scien'Tx USA, Inc..
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 Scien'Tx USA, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Scien'Tx USA, Inc.” (first 1999, latest 2002), across 4 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 Scien'Tx USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scien'Tx USA, Inc. is 76 days.
Which FDA product codes appear under Scien'Tx USA, Inc.?
The most frequent FDA product codes under this applicant name are MNH (Orthosis, Spondylolisthesis Spinal Fixation, 4); MNI (Orthosis, Spinal Pedicle Fixation, 2); KWP (Appliance, Fixation, Spinal Interlaminal, 1).
Next steps
- See all 8 Scien'Tx USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MNH, Scien'Tx USA, Inc.'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.