Data / Medical devices / United States / Keos
Keos: FDA-registered device maker in Naples, FL, United States, 4 510(k) clearances
Keos is registered with the FDA (registration 3013921069) in Naples, FL, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 6, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013921069
- Address
- 5625 Strand Blvd Ste 505, Naples, FL, United States, 34110
- Owner or operator
- Keos (10055802)
- Roles
- Specification developer
- First device listed
- October 8, 2017
- Registered through
- 2027
- Brand names listed
- General Instrument, Keos Anterior Cervical IBFD, Keos IBFD Tray, Keos Lumbar IBFD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Specification developer | 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 6, 2022 | K212450 | Keos Anterior Cervical Interbody Fusion Device System | ODP | Substantially Equivalent | Keos | accessdata.fda.gov |
| December 16, 2019 | K193174 | Keos Lumbar IBFD | MAX | Substantially Equivalent | Keos | accessdata.fda.gov |
| April 10, 2017 | K163386 | Keos Lumbar IBFD | MAX | Substantially Equivalent | Keos | accessdata.fda.gov |
| July 15, 2016 | K160631 | Keos Lumbar IBFD | MAX | Substantially Equivalent | Keos | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Tray, Surgical, Instrument
Updated June 6, 2022. 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.