Mcconnell Orthopedic: FDA clearances and approvals
Mcconnell Orthopedic has 16 FDA 510(k) clearances (first 1987, latest 1991), across 3 product codes in 3 review panels. Median 510(k) review time: 15 days.
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 |
|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | 14 | 14 |
| HTO | Reamer | 1 | 1 |
| IQI | Orthosis, Limb Brace | 1 | 1 |
Review panels
Most recent Mcconnell Orthopedic 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910974 | MCCONNELL SHOULDER BRACE | IQI | 1991-03-21 | 14 |
| K905565 | LATERAL BUTTRESS SUPPORT | FWZ | 1991-02-21 | 71 |
| K905564 | PREP AND OPERATING STAND | FWZ | 1991-02-21 | 71 |
| K885100 | MCCONNELL REAMER GUIDE | HTO | 1989-01-13 | 32 |
| K871840 | MCCONNELL ORTHOPEDIC ANKLE POSITIONER | FWZ | 1987-05-26 | 14 |
| K871839 | MCCONNELL ORTHOPEDIC PELVIC CALIPER SUPPORT | FWZ | 1987-05-26 | 14 |
| K871824 | MCCONNELL ORTHOPEDIC SUSPENSION SYSTEM | FWZ | 1987-05-26 | 15 |
| K871823 | MCCONNELL ORTHOPEDIC TIBIAL POSITIONER | FWZ | 1987-05-26 | 15 |
| K871822 | MCCONNELL ORTHOPEDIC U-HOOK ASSEMBLY | FWZ | 1987-05-26 | 15 |
| K871821 | MCCONNELL ORTHOPEDIC POSTERIOR BODY SUPPORT | FWZ | 1987-05-26 | 15 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mcconnell Orthopedic.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Mcconnell Orthopedic have?
Mcconnell Orthopedic has 16 FDA 510(k) clearances (first 1987, latest 1991), across 3 product codes in 3 review panels.
How long does FDA take to clear Mcconnell Orthopedic's 510(k)s?
The median time from FDA receipt to decision across Mcconnell Orthopedic's cleared 510(k)s is 15 days.
What devices does Mcconnell Orthopedic make?
Its most frequent FDA product codes are FWZ (Operating Room Accessories Table Tray, 14); HTO (Reamer, 1); IQI (Orthosis, Limb Brace, 1).
Has Mcconnell Orthopedic had device recalls?
openFDA lists no recalls under a recalling firm name matching Mcconnell Orthopedic. Related entities may recall under other names.
Next steps
- See all 16 Mcconnell Orthopedic clearances with predicates and recalls
- Run predicate analysis for product code FWZ, Mcconnell Orthopedic's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.