Data / Medical devices / United States / Aptis Medical, LLC.
Aptis Medical, LLC.: FDA-registered device maker in Glenview, KY, United States, 5 510(k) clearances
Aptis Medical, LLC. is registered with the FDA (registration 3004521401) in Glenview, KY, United States. It lists 10 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 3, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004521401
- Address
- 3602 Glenview Ave, Glenview, KY, United States, 40025
- Owner or operator
- APTIS MEDICAL, LLC. (9054354)
- Roles
- Manufacturer
- First device listed
- December 28, 2007
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Manufacturer | accessdata.fda.gov |
| Impactor | HWA | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Wrist, Hemi-, Ulnar | KXE | 2 | Manufacturer | accessdata.fda.gov |
| Reamer | HTO | 1 | Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer | accessdata.fda.gov |
| Template | HWT | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | 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 |
|---|---|---|---|---|---|---|
| May 3, 2019 | K190599 | Aptis Medical Distal Radio Ulnar Joint Implant | KXE | Substantially Equivalent | Aptis Medical, LLC | accessdata.fda.gov |
| April 3, 2015 | K142569 | Aptis Medical Distal Radio Ulnar Joint Implant | KXE | Substantially Equivalent | Aptis Medical, LLC | accessdata.fda.gov |
| October 24, 2008 | K082839 | DISTAL RADIO-ULNAR JOINT IMPLANT | KXE | Substantially Equivalent | Aptis Medical, LLC | accessdata.fda.gov |
| December 7, 2005 | K053119 | DISTAL RADIO-ULNAR JOINT IMPLANT | KXE | Substantially Equivalent | Aptis Medical, LLC | accessdata.fda.gov |
| January 26, 2005 | K040497 | DISTAL RADIO-ULNAR JOINT IMPLANT | KXE | Substantially Equivalent | Aptis Medical, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Reamer
- All makers of Prosthesis, Wrist, Hemi-, Ulnar
- All makers of Template
- All makers of Tray, Surgical
- All makers of Screwdriver
- All makers of Bit, Drill
Updated May 3, 2019. 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.