Disc-O-Tech Medical Technologies, Ltd.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Disc-O-Tech Medical Technologies, Ltd.” (first 2001, latest 2007), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 82 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 | 4 | 4 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 4 | 4 |
| NDN | Cement, Bone, Vertebroplasty | 4 | 4 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 | 1 |
Review panels
- Orthopedic (16)
Most recent Disc-O-Tech Medical Technologies, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071375 | MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) | NDN | 2007-12-21 | 219 |
| K071679 | METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS | HSB | 2007-12-17 | 181 |
| K063067 | CONFIDENCE FENESTRATED INTRODUCER NEEDLE | NDN | 2006-11-03 | 28 |
| K062424 | CONFIDENCE EX HIGH VISCOSITY BONE CEMENT | NDN | 2006-09-14 | 27 |
| K060300 | CONFIDENCE HIGH VISCOSITY BONE CEMENT | NDN | 2006-06-21 | 135 |
| K040612 | SKY BONE EXPANDER SYSTEM (SKY SYSTEM) | HRX | 2004-06-17 | 101 |
| K040939 | SKY BONE EXPANDER SYSTEM (SKY SYSTEM) | HRX | 2004-05-12 | 30 |
| K032730 | FIXION HIP SYSTEM | JDI | 2004-03-26 | 205 |
| K034037 | SKY BONE EXPANDER SYSTEM | HRX | 2004-01-28 | 30 |
| K032358 | B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) | HRX | 2003-12-17 | 140 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Disc-O-Tech Medical Technologies, Ltd..
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 Disc-O-Tech Medical Technologies, Ltd.?
FDA lists 16 510(k) clearances under the applicant name “Disc-O-Tech Medical Technologies, Ltd.” (first 2001, latest 2007), across 7 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 Disc-O-Tech Medical Technologies, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Disc-O-Tech Medical Technologies, Ltd. is 82 days.
Which FDA product codes appear under Disc-O-Tech Medical Technologies, Ltd.?
The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 4); HSB (Rod, Fixation, Intramedullary And Accessories, 4); NDN (Cement, Bone, Vertebroplasty, 4).
Next steps
- See all 16 Disc-O-Tech Medical Technologies, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Disc-O-Tech Medical Technologies, Ltd.'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.