AVALIGN TECHNOLOGIES, Inc.
Fort Wayne, IN, US
AVALIGN TECHNOLOGIES, Inc. appears in FDA device records in Fort Wayne, IN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. 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 3 510(k) clearances for AVALIGN TECHNOLOGIES, Inc. between 2020 and 2026. The busiest year on record is 2020, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252982 | CONDUIT™ ZERO-P™ VA Secured Spacer System | OVE | Substantially Equivalent | |
| K250072 | CONDUIT™ SYNFIX™ Evolution Secured Spacer System | OVD | Substantially Equivalent | |
| K193066 | Steripack cases and Tray Systems | KCT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008864603 | 3008864603 | AVALIGN TECHNOLOGIES, Inc. | 8727 Clinton Park Dr, Fort Wayne, IN 46825 US | 2026 | and 26 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HTWBit, Drill
- JOLCatheter And Tip, Suction
- DXCClamp, Vascular
- HTFCurette
- DWPDilator, Vessel, Surgical
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GEGElevator, Surgical, General & Plastic Surgery
- GENForceps, General & Plastic Surgery
- HDAForceps, Obstetrical
- HCZForceps, Surgical, Gynecological
- GDZHandle, Scalpel
- GDGHook, Surgical, General & Plastic Surgery
- MDMInstrument, Manual, Surgical, General Use
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- GCJLaparoscope, General & Plastic Surgery
- GFJMallet, Surgical, General & Plastic Surgery
- LXHOrthopedic Manual Surgical Instrument
- OJHOrthopedic Tray
- HWMOsteotome
- GFIOsteotome, Manual
- FGMProbe And Director, Gastro-Urology
- HTRRasp
- GACRasp, Surgical, General & Plastic Surgery
- HTOReamer
- GADRetractor
- GZTRetractor, Self-Retaining, For Neurosurgery
- HTXRongeur
- HAERongeur, Manual
- LRWScissors, General, Surgical
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- FSMTray, Surgical, Instrument
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain