Data / Medical devices / France / S.M.A.I.O
S.M.A.I.O: FDA-registered device maker in SAINT-PRIEST Auvergne-Rhone-Alpes, France, 11 510(k) clearances
S.M.A.I.O is registered with the FDA (registration 3015383864) in SAINT-PRIEST Auvergne-Rhone-Alpes, France. It lists 19 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 4, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3015383864
- Address
- 2 Place Berthe Morisot Parc Technologique, SAINT-PRIEST Auvergne-Rhone-Alpes, France, 69800
- Owner or operator
- S.M.A.I.O (10077967)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 8, 2020
- Registered through
- 2026
- Brand names listed
- #1 instruments tray, #1 pedicle screws rack, #2 instruments tray, #2 pedicle screws rack, #3 instruments tray, #4 instruments tray - Dominos and sacral plates, 1/4" T-handle, 1/4" T-rachet handle and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Awl | HWJ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Bender | HXW | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Pusher, Socket | HXO | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Film Marking, Radiographic | JAC | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Wrench | HXC | 1 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| September 4, 2026 | K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB | Substantially Equivalent | S.M.A.I.O | accessdata.fda.gov |
| August 17, 2026 | K261500 | KBA3D (v2.4.0) | LLZ | Substantially Equivalent | S.M.A.I.O | accessdata.fda.gov |
| July 1, 2026 | K253802 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB | Substantially Equivalent | S.M.A.I.O | accessdata.fda.gov |
| January 7, 2026 | K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB | Substantially Equivalent | S.M.A.I.O | accessdata.fda.gov |
| December 17, 2025 | K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB | Substantially Equivalent | S.M.A.I.O | accessdata.fda.gov |
| July 8, 2025 | K251804 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB | Substantially Equivalent | S.M.A.I.O | accessdata.fda.gov |
| May 30, 2023 | K223841 | KBA3D | LLZ | Substantially Equivalent | S.M.A.I.O | accessdata.fda.gov |
| June 9, 2022 | K211981 | KHEIRON® Spinal Fixation System | NKB | Substantially Equivalent | S.M.A.I.O | accessdata.fda.gov |
| May 6, 2022 | K213975 | KEOPS Balance Analyzer 3D | LLZ | Substantially Equivalent | S.M.A.I.O | accessdata.fda.gov |
| August 10, 2021 | K211414 | KHEIRON Spinal Fixation System | NKB | Substantially Equivalent | S.M.A.I.O | accessdata.fda.gov |
| October 5, 2020 | K201659 | KHEIRON® Spinal Fixation System | NKB | Substantially Equivalent | S.M.A.I.O | accessdata.fda.gov |
Compare with other makers
- All makers of Bit, Drill
- All makers of Instrument, Compression
- All makers of Osteotome
- All makers of System, Image Processing, Radiological
- All makers of Appliance, Fixation, Spinal Interlaminal
- All makers of Thoracolumbosacral Pedicle Screw System
Updated September 4, 2026. 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.