Data / Medical devices / United States / Mcginley Orthopaedic Innovations, Inc
Mcginley Orthopaedic Innovations, Inc: FDA-registered device maker in Casper, WY, United States, 2 510(k) clearances
Mcginley Orthopaedic Innovations, Inc is registered with the FDA (registration 3011569539) in Casper, WY, United States. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 25, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011569539
- Address
- 234 E. 1st Street Ste 242, Casper, WY, United States, 82601
- Owner or operator
- McGinley Orthopaedic Innovations, INC (10048881)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- March 16, 2015
- Registered through
- 2026
- Brand names listed
- Equalizer: Offset Reference Guide, IntelliSense Drill, Lever Action Plate System, McGinley AR, Revolver: Universal Drill Bit Guide, Universal Chuck Set for the IntelliSense Drill System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bit, Surgical | GFG | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Motor, Surgical Instrument, Ac-Powered | GEY | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 25, 2020 | K200834 | Lever Action Plate System | HRS | Substantially Equivalent | Mcginley Orthpaedic Innovations, LLC | accessdata.fda.gov |
| February 20, 2015 | K143191 | IntelliSense Drill | HWE | Substantially Equivalent | Mcginley Innovations | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- All makers of Motor, Surgical Instrument, Ac-Powered
- All makers of Bit, Drill
- All makers of Bit, Surgical
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Plate, Fixation, Bone
Updated June 25, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.