Cintor Orthopaedic Div.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Cintor Orthopaedic Div.” (first 1980, latest 1981), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 34 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | 2 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | 1 | 1 |
| JEC | Component, Traction, Invasive | 1 | 1 |
| LZN | Cement Obturator | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Cintor Orthopaedic Div. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K811451 | RADIAL HEAD PROSTHESIS | JDB | 1981-06-09 | 18 |
| K810540 | KNEE PROSTHESIS | HRY | 1981-04-07 | 39 |
| K810353 | HARRIS CEMENT RESTRICTOR | LZN | 1981-02-23 | 13 |
| K803106 | AGINSKY NAIL | HSB | 1981-02-12 | 65 |
| K803074 | FERNORAL HIP PROSTHESIS | JDI | 1981-01-08 | 34 |
| K802627 | ORTRON 90* HIP PROSTHESIS | JDI | 1980-12-16 | 54 |
| K802814 | ORTHOFIX AXIALEXTERNAL FIXATION SYS. | JEC | 1980-12-10 | 33 |
Recalls
openFDA lists no recalls under a recalling firm named Cintor Orthopaedic Div..
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 Cintor Orthopaedic Div.?
FDA lists 7 510(k) clearances under the applicant name “Cintor Orthopaedic Div.” (first 1980, latest 1981), across 6 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 Cintor Orthopaedic Div.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cintor Orthopaedic Div. is 34 days.
Which FDA product codes appear under Cintor Orthopaedic Div.?
The most frequent FDA product codes under this applicant name are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 2); HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer, 1); HSB (Rod, Fixation, Intramedullary And Accessories, 1).
Next steps
- See all 7 Cintor Orthopaedic Div. clearances with predicates and recalls
- Run predicate analysis for product code JDI, Cintor Orthopaedic Div.'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.