Danek Medical, Inc.: FDA filings under this applicant name
FDA lists 56 510(k) clearances under the applicant name “Danek Medical, Inc.” (first 1981, latest 2000), across 27 product codes in 7 review panels. Median 510(k) review time under this name: 89 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | 16 | 16 |
| HRX | Arthroscope | 5 | 5 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 | 4 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 3 |
| MNI | Orthosis, Spinal Pedicle Fixation | 3 | 3 |
| ILI | Sling, Arm | 2 | 2 |
| JDQ | Cerclage, Fixation | 2 | 2 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 | 2 |
| FNJ | Bed, Manual | 1 | 1 |
| GFF | Bur, Surgical, General & Plastic Surgery | 1 | 1 |
Plus 17 more product codes.
Review panels
- Orthopedic (40)
- Physical Medicine (11)
- Gastroenterology and Urology (1)
- General Hospital (1)
- Neurology (1)
- Ophthalmic (1)
- General and Plastic Surgery (1)
Most recent Danek Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994122 | BONE GRAFT WASHER, MODEL 9090114 - 9090118 | KWQ | 2000-02-18 | 73 |
| K993810 | CD HORIZON SPINAL SYSTEM | MNH | 2000-02-03 | 85 |
| K993855 | ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 1999-12-15 | 30 |
| K991528 | MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR | MNH | 1999-05-28 | 25 |
| K990603 | MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM | KWQ | 1999-03-10 | 15 |
| K982875 | MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM | KWQ | 1999-01-19 | 158 |
| K984522 | MODIFICATION OF TSRH SPINAL SYSTEM | MNI | 1999-01-06 | 16 |
| K982154 | MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM | MNI | 1998-07-13 | 24 |
| K970599 | TOWNLEY PEDICLE SCREW PLATING SYSTEM | MNI | 1998-03-20 | 395 |
| K943827 | SPINE FIXATION | MNH | 1996-02-14 | 558 |
46 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Danek Medical, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Danek Group, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Danek Medical, Inc.?
FDA lists 56 510(k) clearances under the applicant name “Danek Medical, Inc.” (first 1981, latest 2000), across 27 product codes in 7 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 Danek Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Danek Medical, Inc. is 89 days.
Which FDA product codes appear under Danek Medical, Inc.?
The most frequent FDA product codes under this applicant name are KWP (Appliance, Fixation, Spinal Interlaminal, 16); HRX (Arthroscope, 5); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 4).
Next steps
- See all 56 Danek Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KWP, Danek Medical, 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.