Endius, Inc.: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Endius, Inc.” (first 1997, latest 2008), across 10 product codes in 5 review panels. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| HRX | Arthroscope | 9 | 9 |
| NKB | Thoracolumbosacral Pedicle Screw System | 7 | 7 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 4 | 4 |
| MNI | Orthosis, Spinal Pedicle Fixation | 4 | 4 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| GWG | Endoscope, Neurological | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 | 1 |
Review panels
- Orthopedic (28)
- General and Plastic Surgery (2)
- Ear, Nose and Throat (1)
- Gastroenterology and Urology (1)
- Neurology (1)
Most recent Endius, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080258 | MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM | NKB | 2008-03-10 | 39 |
| K073510 | ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM | NKB | 2008-02-11 | 60 |
| K073267 | ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM | NKB | 2008-01-30 | 71 |
| K072840 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM | NKB | 2007-12-07 | 64 |
| K070282 | ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM | NKB | 2007-09-06 | 220 |
| K070367 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM | NKB | 2007-04-12 | 63 |
| K061345 | MODIFICATION TO ENDIUS ATAVI SYSTEM | HRX | 2006-06-06 | 22 |
| K060990 | ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM | NKB | 2006-04-26 | 16 |
| K060683 | ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM | KWP | 2006-04-18 | 34 |
| K053267 | ENDIUS ATAVI SYSTEM | HRX | 2006-01-13 | 51 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Endius, 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 Endius, Inc.?
FDA lists 33 510(k) clearances under the applicant name “Endius, Inc.” (first 1997, latest 2008), across 10 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Endius, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Endius, Inc. is 60 days.
Which FDA product codes appear under Endius, Inc.?
The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 9); NKB (Thoracolumbosacral Pedicle Screw System, 7); KWP (Appliance, Fixation, Spinal Interlaminal, 4).
Next steps
- See all 33 Endius, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Endius, 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 (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.