Disco-O-Tech Medical Technologies, Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Disco-O-Tech Medical Technologies, Ltd.” (first 1999, latest 2003), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 75 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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 6 | 6 |
| JDS | Nail, Fixation, Bone | 2 | 2 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
Review panels
- Orthopedic (9)
Most recent Disco-O-Tech Medical Technologies, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032588 | MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM) | HSB | 2003-09-12 | 21 |
| K031401 | FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) | KTT | 2003-08-06 | 93 |
| K023437 | FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL | HSB | 2002-11-14 | 30 |
| K021324 | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM) | HSB | 2002-05-23 | 27 |
| K012967 | MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM | HSB | 2001-10-04 | 30 |
| K003212 | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) | JDS | 2000-12-28 | 76 |
| K003215 | MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) | JDS | 2000-12-27 | 75 |
| K002783 | FIXION INTERLOCKING NAIL (FIXION IL NAIL) | HSB | 2000-12-05 | 90 |
| K990717 | FIXION INTRAMEDULLARY NAILING SYSTEM | HSB | 1999-06-02 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Disco-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.
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.
- Disco, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Disco-O-Tech Medical Technologies, Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Disco-O-Tech Medical Technologies, Ltd.” (first 1999, latest 2003), across 3 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 Disco-O-Tech Medical Technologies, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Disco-O-Tech Medical Technologies, Ltd. is 75 days.
Which FDA product codes appear under Disco-O-Tech Medical Technologies, Ltd.?
The most frequent FDA product codes under this applicant name are HSB (Rod, Fixation, Intramedullary And Accessories, 6); JDS (Nail, Fixation, Bone, 2); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 1).
Next steps
- See all 9 Disco-O-Tech Medical Technologies, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HSB, Disco-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 (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.