O'Tec Corp.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “O'Tec Corp.” (first 1988, latest 1994), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 13 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 4 | 4 |
| HTY | Pin, Fixation, Smooth | 3 | 3 |
| HWC | Screw, Fixation, Bone | 3 | 3 |
| JDR | Staple, Fixation, Bone | 3 | 3 |
| JDW | Pin, Fixation, Threaded | 3 | 3 |
| IOR | Wheelchair, Mechanical | 2 | 2 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 1 | 1 |
Review panels
- Orthopedic (21)
- Physical Medicine (2)
Most recent O'Tec Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943293 | SCC22/ SCC26 SHOWER COMMODE CHAIR | IOR | 1994-08-19 | 42 |
| K910093 | FUTURA FEMORAL HIP STEM | JDI | 1991-07-01 | 174 |
| K905358 | CANCELLOUS SCREW | HWC | 1991-01-04 | 37 |
| K905357 | CORTICAL BONE SCREW (EUROPEAN STYLE) | HWC | 1991-01-04 | 37 |
| K905355 | BROAD SELF-COMPRESSING PLATE | HRS | 1991-01-04 | 37 |
| K905347 | HAGIE PIN | JDW | 1991-01-04 | 37 |
| K905333 | U.S. TYPE CRUCIATE SLOT BONE SCREW | HWC | 1991-01-04 | 37 |
| K905364 | ROUND STAPLE | JDR | 1990-12-11 | 13 |
| K905363 | FIXATION STAPLE | JDR | 1990-12-11 | 13 |
| K905362 | BARBED SQUARE STAPLE | JDR | 1990-12-11 | 13 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named O'Tec Corp..
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 O'Tec Corp.?
FDA lists 23 510(k) clearances under the applicant name “O'Tec Corp.” (first 1988, latest 1994), across 10 product codes in 2 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 O'Tec Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name O'Tec Corp. is 13 days.
Which FDA product codes appear under O'Tec Corp.?
The most frequent FDA product codes under this applicant name are KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 4); HTY (Pin, Fixation, Smooth, 3); HWC (Screw, Fixation, Bone, 3).
Next steps
- See all 23 O'Tec Corp. clearances with predicates and recalls
- Run predicate analysis for product code KTT, O'Tec Corp.'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.