Spineguard, Inc.
Boulder, CO, US
SPINEGUARD, INC. appears in FDA device records in Boulder, CO. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Spineguard, Inc. between 2013 and 2024. The busiest year on record is 2013, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241895 | Cannulated PsiFGuard | SCY | Substantially Equivalent | |
| K220160 | PediGuard Threaded | PDQ | Substantially Equivalent | |
| K201454 | DSG Connect Technology | PDQ | Substantially Equivalent | |
| K162884 | SpineGuard DSG Zavation Screw System | HBG | Substantially Equivalent | |
| K152747 | DSG Threaded Drill System | PDQ | Substantially Equivalent | |
| K143159 | Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS | PDQ | Substantially Equivalent | |
| K123390 | PEDIGUARD NERVE DETECTOR SYSTEM | PDQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007566524 | 3007566524 | SPINEGUARD, INC. | 1434 Spruce Street, Boulder, CO 80302 US | 2026 | No device listings on this registration |
| 3008102049 | 3008102049 | SPINEGUARD, SA | 10, Cours Louis Lumiere, Vincennes Paris 94300 FR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GEACannula, Surgical, General & Plastic Surgery
- HBGDrills, Burrs, Trephines & Accessories (Manual)
- FZXGuide, Surgical, Instrument
- MDMInstrument, Manual, Surgical, General Use
- PDQNeurosurgical Nerve Locator
- SCYSacroiliac Joint Guidewire Placement Device
- ETNStimulator, Nerve
- GAHStylet, Surgical, General & Plastic Surgery
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain